Inolitazone Dihydrochloride and Paclitaxel in Treating Patients with Advanced Anaplastic Thyroid Cancer

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Status: Active

Description

This phase II trial studies how well inolitazone dihydrochloride (efatutazone dihydrochloride) and paclitaxel work in treating patients with anaplastic thyroid cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as efatutazone dihydrochloride and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically diagnosed advanced anaplastic thyroid cancer (ATC)
  • Patients must have measurable disease
  • Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)
  • Patients should have resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, grade 1
  • There is no limit to the number of prior lines of treatment a patient has received
  • No treatment with chemotherapy, radiation therapy, immunotherapy, biological therapy, hormonal therapy, or other thiazolidinediones (TZDs) =< 21 days before study registration
  • No prior taxane therapy =< 6 months, except as a radiosensitizer
  • No history of the following: * Class III or IV congestive heart failure (CHF) * Grade 3 or 4 thromboembolic event =< 6 months * Pericardial effusion =< 12 months (any grade) * Pericardial involvement with tumor * Grade 2 or higher pleural effusion =< 6 months
  • No current symptomatic, untreated, or uncontrolled brain metastases present
  • No major surgery =< 14 days prior to registration
  • No grade 2 or higher neuropathy
  • No known history of severe hypersensitivity reactions to any of the components of efatutazone or paclitaxel formulations
  • Not pregnant and not nursing; women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Patients with diabetes mellitus requiring concurrent treatment with insulin or thiazolidinedione (TZD) oral agents are not eligible
  • Patients with known hypersensitivity to any TZD oral agents are not eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance >= 60 mL/min
  • Bilirubin =< 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN)
  • Although they will not be considered formal eligibility (exclusion) criteria, physicians should recognize that the following may seriously increase the risk to the patient entering this protocol: * Psychiatric illness which would prevent the patient from giving informed consent * Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient * Patients with a “currently active” second malignancy other than non-melanoma skin cancers; patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for >= 3 years; there is an exception for patients with a history of well differentiated thyroid cancer that has progressed to anaplastic thyroid cancer * Patients who cannot swallow oral formulations of the agent(s) * Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study ; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) * Efatutazone is metabolized by cytochrome P450, family 3, subfamily A, polypeptide 4/5 (CYP3A4/5), and inhibits CYP2C8, 2C9, 2C19, and 3A4, and is a substrate of P-glycoprotein (PgP) and breast cancer resistance protein (BCRP)

Locations & Contacts

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Regional Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 907-264-2933
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Radiation Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arizona

Phoenix
Mayo Clinic Hospital
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Scottsdale
Mayo Clinic in Arizona
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 818-847-4793
Email: Madonna.Johnson@providence.org

Colorado

Aurora
University of Colorado Hospital
Status: Active
Contact: Site Public Contact
Phone: 720-848-0650

Connecticut

Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu
Yale University
Status: Active
Contact: Site Public Contact
Phone: 203-785-5702
Email: canceranswers@yale.edu

Delaware

Lewes
Beebe Medical Center
Status: Active
Contact: Site Public Contact
Phone: 302-645-3770
Email: Dmiskin@Beebehealthcare.org
Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Christiana Gynecologic Oncology LLC
Status: Temporarily closed to accrual
Contact: Gregory Andrew Masters
Phone: 302-733-6227
Delaware Clinical and Laboratory Physicians PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Regional Hematology and Oncology PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Rehoboth Beach
Beebe Health Campus
Status: Active
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org
Seaford
Nanticoke Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-645-3100
Email: Dmiskin@Beebehealthcare.org
Wilmington
Christiana Care Health System-Wilmington Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015

Hawaii

Aiea
Hawaii Oncology Inc-Pali Momi
Status: Active
Contact: Site Public Contact
Phone: 808-487-7447
Pali Momi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-486-6000
The Cancer Center of Hawaii-Pali Momi
Status: Active
Contact: Site Public Contact
Phone: 808-678-9000
Honolulu
Hawaii Cancer Care Inc-Liliha
Status: Active
Contact: Site Public Contact
Phone: 808-536-4888
Hawaii Cancer Care Inc-POB II
Status: Active
Contact: Site Public Contact
Phone: 808-524-6115
Hawaii Oncology Inc-Kuakini
Status: Active
Contact: Site Public Contact
Phone: 808-531-8521
Kapiolani Medical Center for Women and Children
Status: Active
Contact: Site Public Contact
Phone: 808-983-6090
Kuakini Medical Center
Status: Active
Contact: Site Public Contact
Phone: 808-547-9816
Queen's Medical Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Straub Clinic and Hospital
Status: Active
Contact: Site Public Contact
Phone: 808-522-4333
The Cancer Center of Hawaii-Liliha
Status: Active
Contact: Site Public Contact
Phone: 808-547-6881
University of Hawaii Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 808-586-2979
Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
Status: Active
Contact: Site Public Contact
Phone: 808-535-7960

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Meridian
Idaho Urologic Institute-Meridian
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org

Illinois

Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu

Kansas

Chanute
Cancer Center of Kansas - Chanute
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Dodge City
Cancer Center of Kansas - Dodge City
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
El Dorado
Cancer Center of Kansas - El Dorado
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Fort Scott
Cancer Center of Kansas - Fort Scott
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Garden City
Central Care Cancer Center - Garden City
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Great Bend
Central Care Cancer Center - Great Bend
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Independence
Cancer Center of Kansas-Independence
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Kingman
Cancer Center of Kansas-Kingman
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Minimally Invasive Surgery Hospital
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Liberal
Cancer Center of Kansas-Liberal
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Manhattan
Cancer Center of Kansas-Manhattan
Status: Active
Contact: Site Public Contact
Phone: 316-268-5784
Email: Keisha.humphries@ascension.org
McPherson
Cancer Center of Kansas - McPherson
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Newton
Cancer Center of Kansas - Newton
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Overland Park
Menorah Medical Center
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Saint Luke's South Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Parsons
Cancer Center of Kansas - Parsons
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Pratt
Cancer Center of Kansas - Pratt
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Salina
Cancer Center of Kansas - Salina
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wellington
Cancer Center of Kansas - Wellington
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wichita
Associates In Womens Health
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas - Wichita
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Via Christi Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org
Winfield
Cancer Center of Kansas - Winfield
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Massachusetts

Springfield
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 413-748-9234

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
University of Michigan Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-865-1125
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caro
Caro Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clarkston
Hematology Oncology Consultants-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Newland Medical Associates-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Dearborn
Beaumont Hospital-Dearborn
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 248-551-7695
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-1784
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Genesee Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Genesys Hurley Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Hurley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Gorsse Pointe Woods
Lymphoma Clinic of Michigan
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Grosse Pointe Woods
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Grosse Pointe Woods
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Jackson
Allegiance Health
Status: Active
Contact: Site Public Contact
Phone: 517-788-4800
Lansing
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Livonia
Hope Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Macomb Township
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: Active
Contact: Site Public Contact
Phone: 989-343-2487
Pontiac
21st Century Oncology-Pontiac
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Hope Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Newland Medical Associates-Pontiac
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Port Huron
Lake Huron Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 702-384-0013
Email: research@sncrf.org
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Mary's of Michigan
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Tawas City
Saint Joseph Health System-Tawas City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Warren
Advanced Breast Care Center PLLC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bhadresh Nayak MD PC-Warren
Status: Active
Contact: Tareq Al Baghdadi
Phone: 734-712-3671
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Warren
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint John Macomb-Oakland Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: Active
Contact: Site Public Contact
Phone: 989-343-2487
Ypsilanti
Huron Gastroenterology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
IHA Hematology Oncology Consultants-Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Bemidji
Sanford Clinic North-Bemidgi
Status: Active
Contact: Site Public Contact
Phone: 218-333-5000
Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Wyoming
Fairview Lakes Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Bolivar
Central Care Cancer Center - Bolivar
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Independence
Centerpoint Medical Center LLC
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Joplin
Freeman Health System
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Kansas City
Heartland Hematology and Oncology Associates Incorporated
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Research Medical Center
Status: Active
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Saint Luke's Hospital of Kansas City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Lee's Summit
Saint Luke's East - Lee's Summit
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Liberty
Liberty Radiation Oncology Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 913-948-5588
Email: aroland@kccop.org
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-7504
Email: jrichards@research.pcrmc.com
Saint Joseph
Heartland Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 816-271-7937
Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-6770
Saint Louis Cancer and Breast Institute-South City
Status: Active
Contact: Site Public Contact
Phone: 314-353-1870
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Anaconda
Community Hospital of Anaconda
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Saint Patrick Hospital - Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-327-3118
Email: amy.hanneman@providence.org

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: tamara.fischer@sanfordhealth.org
Fargo
Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-437-4010

Ohio

Cincinnati
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 513-558-4553
Email: uchealthnews@uc.edu
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
West Chester
University Pointe
Status: Active
Contact: Site Public Contact
Email: clinicaltrials@ucphysicians.com

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: Active
Contact: Site Public Contact
Phone: 918-505-3200

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bend
Saint Charles Health System
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Active
Contact: Site Public Contact
Phone: 541-269-8392
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Ontario
Saint Alphonsus Medical Center-Ontario
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Oregon City
Providence Willamette Falls Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Redmond
Saint Charles Health System-Redmond
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Danville
Geisinger Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
East Stroudsburg
Pocono Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-422-1700
Email: ann.foster@lvhn.org
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: Active
Contact: Site Public Contact
Phone: 570-459-2901
Email: HemonCCTrials@geisinger.edu
Lehigh Valley Hospital-Hazleton
Status: Active
Contact: Site Public Contact
Phone: 773-702-9171
Email: protocols@AllianceNCTN.org
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
Lewistown
Lewistown Hospital
Status: Active
Contact: Site Public Contact
Phone: 717-242-7703
Email: HemonCCTrials@geisinger.edu
Pottsville
Geisinger Cancer Services-Pottsville
Status: Active
Contact: Site Public Contact
Phone: 800-275-6401
Email: HemonCCTrials@geisinger.edu
Scranton
Community Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-703-4768
Email: HemonCCTrials@geisinger.edu
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Email: HemonCCTrials@geisinger.edu
State College
Geisinger Medical Group
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Email: HemonCCTrials@geisinger.edu

South Carolina

Easley
Greenville Health System Cancer Institute-Easley
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville
Greenville Health System Cancer Institute-Andrews
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Butternut
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Health System Cancer Institute-Faris
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greenville Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Greer
Greenville Health System Cancer Institute-Greer
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Seneca
Greenville Health System Cancer Institute-Seneca
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org
Spartanburg
Greenville Health System Cancer Institute-Spartanburg
Status: Active
Contact: Site Public Contact
Phone: 864-241-6251
Email: kwilliams8@ghs.org

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Anacortes
Cancer Care Center at Island Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 360-299-1336
Email: eoates@islandhospital.org
Bellevue
Swedish Cancer Institute-Eastside Oncology Hematology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Email: CancerResearch@swedish.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Centralia
Providence Regional Cancer System-Centralia
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Edmonds
Swedish Medical Center-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Everett
Providence Regional Cancer Partnership
Status: Active
Contact: Site Public Contact
Phone: 425-261-3529
Email: marilyn.birchman@providence.org
Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Site Public Contact
Phone: 509-783-4637
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Longview
PeaceHealth Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Port Townsend
Jefferson Healthcare
Status: Active
Contact: Site Public Contact
Phone: 360-344-3091
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Seattle
Kaiser Permanente Washington
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Minor and James Medical PLLC
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 206-386-9501
Pacific Gynecology Specialists
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Ballard Campus
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Sedro-Woolley
PeaceHealth United General Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-788-8240
Shelton
Providence Regional Cancer System-Shelton
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Spokane
Evergreen Hematology and Oncology PS
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-464-2873
Rockwood Cancer Treatment Center-DHEC-Downtown
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Rockwood North Cancer Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Spokane Valley
Rockwood Clinic Cancer Treatment Center-Valley
Status: Active
Contact: Site Public Contact
Phone: 509-724-4454
Email: apope@rockwoodclinic.com
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 509-897-5993
Email: Cheryl.Dodd@providence.org
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 509-574-3535
Email: Memorial-ClinicalTrials@yvmh.org
Yelm
Providence Regional Cancer System-Yelm
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org

Wisconsin

Milwaukee
Froedtert and the Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-4380
New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Wyoming

Cody
Billings Clinic-Cody
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine if the combination of paclitaxel and efatutazone (efatutazone dihydrochloride) improves the confirmed response rate in patients with advanced anaplastic thyroid cancer.

SECONDARY OBJECTIVES:

I. To estimate the overall survival (OS), duration of response, progression-free survival (PFS), and adverse event rates for the combination of paclitaxel and efatutazone.

TERTIARY OBJECTIVES:

I. The association of biomarkers with clinical outcome data will be assessed in an exploratory translational analysis.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 3 hours on day 1 and efatutazone dihydrochloride orally (PO) twice daily (BID) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 28 days, every 8 weeks until disease progression, and then every 6 months for 5 years.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Robert C. Smallridge

Trial IDs

Primary ID A091305
Secondary IDs NCI-2014-00686
Clinicaltrials.gov ID NCT02152137