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Clinical Trials (PDQ®)

Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentClosed18 and overNCINCI-2011-03812
CDR0000681448, GOG-0262/ACRIN 6695, GOG-0262, U10CA027469, U10CA180868, NCT01167712

Trial Description

Summary

This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known whether giving paclitaxel once every three weeks is more effective than giving paclitaxel once a week.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if the weekly paclitaxel regimen increases the time until first progression or death (progression-free survival [PFS]) compared to the every-3-week paclitaxel regimen in women with primary stage II, III or IV epithelial ovarian, peritoneal or fallopian tube cancer who are receiving carboplatin with or without bevacizumab.

SECONDARY OBJECTIVES:

I. To determine if the weekly paclitaxel increases the duration of overall survival compared to the every-3-week paclitaxel when combined with carboplatin with or without bevacizumab.

II. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to the incidence of severe or serious adverse events when it is combined with carboplatin with or without bevacizumab.

III. To compare the weekly paclitaxel to the every-3-week paclitaxel with respect to patients' self-reported quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O)-Trial Outcome Index (TOI), when paclitaxel is combined with carboplatin with or without bevacizumab. (As of 02/08/2012, the QOL portion of this study is complete; patients enrolled after this date will not have QOL assessments)

TERTIARY OBJECTIVES:

I. To evaluate single nucleotide polymorphisms (SNPs) associated with progression-free survival and toxicity in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer using genome wide association studies (GWAS).* II. To evaluate genomic signatures in tumor tissues which are predictive for patient survival in advanced stage epithelial ovarian, peritoneal and fallopian tube cancer.* III. To evaluate the association between serum and plasma biomarkers and response to anti-angiogenesis therapy in advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.*

NOTE: *As of 02/08/2012, the translational research portion of this study is complete; patients enrolled after this date will not have TR specimens collected.

IMAGING PRIMARY OBJECTIVES:

I. To determine whether larger changes in the tumor perfusion parameters from baseline timepoint (T0) to early-therapy T2 are prognostic of higher progression-free survival (PFS) rate at 6 months (PFS-6) from enrollment in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.***

IMAGING SECONDARY OBJECTIVES:

I. To determine whether larger changes in tumor perfusion parameters from baseline T0 to intermediate T1 and from T1 to T2 are prognostic of higher PFS-6 in patients treated with weekly or every-3-week paclitaxel regimens, who are receiving carboplatin with or without bevacizumab.*** II. To determine whether larger changes in tumor perfusion parameters values from T0 to T1, T0 to T2, and T1 to T2 are prognostic of better overall survival in all treatment arms.*** III. To assess the association between changes in tumor perfusion parameters before and after chemotherapy initiation (T0 to T1) and subsequent best tumor response according to standard anatomic Response Evaluation Criteria in Solid Tumors (RECIST).*** IV. To assess the association between tumor perfusion parameters before chemotherapy and subsequent best tumor response according to RECIST, PFS-6, and overall survival.*** V. To test the assumption that tumor perfusion parameters are reliable, user-independent, and reproducible parameters of tumor microvascular characteristics; a subgroup of 15 patients will have repeat computed tomography (CT) perfusion studies at the intermediate T1 time point.***

NOTE: ***Patients enrolled after February 8, 2012 must participate in the ACRIN 6695 component at ACRIN-qualified institutions.

OUTLINE: Patients are randomized to 1 of 2 treatment arms (beginning on 04-30-2012, the trial is no longer randomized and the chemotherapy regimen is selected and declared prior to enrolling in the study).

ARM I (adjuvant chemotherapy suboptimally debulked): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.

ARM II (neoadjuvant chemotherapy with interval cytoreductive surgery): Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.

Patients in both arms may receive optional** bevacizumab IV over 30-90 minutes on day 1 beginning in course 2. Courses of bevacizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients in Arm II receive bevacizumab during courses 2, 5, and 6 only.

NOTE: **Before enrolling onto this study, each patient chooses whether the study treatment will include concurrent and maintenance bevacizumab.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients:
  • Patients must have measurable disease; at least one target lesion must have a minimum length of 1 cm in both the long and short axis (determined at the local site); for primary surgery patients, if no radiographic evidence of measurable disease is obtained prior to registration this can be based on surgical findings; imaging then would need to be completed in the 14 days between Gynecology Oncology Group (GOG) registration and chemotherapy initiation
  • Primary Surgery Patients:
  • Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
  • Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:
  • For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
  • Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine =< 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients must have a GOG performance status of 0, 1, or 2
  • Patients must be entered within 12 weeks of diagnostic/staging surgery
  • Patients who have met the pre-entry requirements
  • An approved informed consent and authorization permitting release of personal health information and must be signed by the patient or guardian
  • Only applies for patients who elect to receive bevacizumab:
  • Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not high-dose progestins for management of anorexia while on protocol-directed therapy or prior to disease progression due to thrombophlebitis risk
  • Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit of normal; (heparin, lovenox or alternative anticoagulants are acceptable)
  • All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be enrolled in the advanced imaging protocol; patients receiving adjuvant or neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does not apply to those patients entered after 02/08/2012: if a patient declines to participate in the perfusion imaging portion of the protocol, a clinical rationale for declination of imaging form will be completed as part of the data submission for ACRIN 6695
  • ACRIN 6695 Eligible Patients:
  • Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed tomography (CT) will be assessed by the American College of Radiology (ACR) Imaging Core Lab: At least one target lesion must have a minimum length of 1 cm in both the long and short axis (as determined by the local site), at least half of the target lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced CT, and at least half of the lesion must have maximum enhancement greater than or equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core Lab)

Exclusion Criteria:

  • Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
  • Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
  • With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
  • Patients with acute hepatitis or active infection that requires parenteral antibiotics
  • Patients with clinically significant cardiovascular disease; this includes:
  • Myocardial infarction or unstable angina < 6 months prior to registration
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
  • Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
  • Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
  • Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Statistical and Data Center (SDC) randomization desk for uncertainty in this regard
  • Patients with known allergy to cremophor or polysorbate 80
  • Only applies to patients who elect to receive bevacizumab:
  • Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
  • Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
  • Patients with CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
  • Patients with a history of CVA within six months
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
  • Patients with or with anticipation of invasive procedures as defined below:
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
  • Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression such as colostomy or enterostomy reversal, secondary cytoreductive surgery, or second look surgery; please consult with the SDC Randomization Desk prior to patient entry for any questions related to the classification of surgical procedures
  • Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
  • Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
  • Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)
  • ACRIN 6695 Ineligible Patients:
  • Patients with contraindication to iodinated contrast for perfusion CT imaging
  • Patients who receive Metformin within 48 hours before perfusion CT imaging

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

John ChanPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Rodney P Rocconi Ph: 251-445-9870
  Email: pfrancisco@usouthal.edu
Arkansas
  Hot Springs
 St. Joseph's Mercy Cancer Center
 Manjusha Kota Ph: 888-823-5923
  Email: ctsucontact@westat.com
California
  Castro Valley
 East Bay Radiation Oncology Center
 James H. Feusner Ph: 510-450-7600
 Valley Medical Oncology Consultants - Castro Valley
 James H. Feusner Ph: 510-450-7600
  Fremont
 Valley Medical Oncology
 James H. Feusner Ph: 510-450-7600
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Michael T. McHale Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Scott E. Lentz Ph: 626-564-3455
  Martinez
 Contra Costa Regional Medical Center
 James H. Feusner Ph: 510-450-7600
  Mountain View
 El Camino Hospital Cancer Center
 James H. Feusner Ph: 510-450-7600
  Oakland
 Alta Bates Summit Medical Center - Summit Campus
 James H. Feusner Ph: 510-450-7600
 Bay Area Breast Surgeons, Incorporated
 James H. Feusner Ph: 510-450-7600
 CCOP - Bay Area Tumor Institute
 James H. Feusner Ph: 510-450-7600
 Highland General Hospital
 James H. Feusner Ph: 510-450-7600
 Larry G Strieff MD Medical Corporation
 James H. Feusner Ph: 510-450-7600
 Tom K Lee, Incorporated
 James H. Feusner Ph: 510-450-7600
  San Pablo
 Doctors Medical Center - San Pablo Campus
 James H. Feusner Ph: 510-450-7600
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
Colorado
  Fort Collins
 Front Range Cancer Specialists
 Robert F Marschke Ph: 970-482-3328
 Poudre Valley Hospital
 Paolo Romero Ph: 970-495-8226
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Mark E Borowsky Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Mark E Borowsky Ph: 302-733-6227
Florida
  Clearwater
 Morton Plant Hospital
 Hector A. Arango Ph: 727-461-8519
  Fort Myers
 Florida Gynecologic Oncology - Fort Myers
 Edward C. Grendys Ph: 800-874-7502
  Lakeland
 Center for Cancer Care and Research at Watson Clinic, LLP
 Richard J Cardosi Ph: 863-680-7780
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 James E Kendrick Ph: 407-303-5623
Hawaii
  Honolulu
 MBCCOP - Hawaii
 Michael E. Carney Ph: 808-983-6090
Illinois
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Donna Marie Smith Ph: 708-226-4357
  Moline
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas L. Constantinou Ph: 319-363-2690
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Warrenville
 Central Dupage Cancer Center
 Laura E Horvath Ph: 773-834-7424
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 317-783-8918
  Munster
 Community Hospital
 Mohamad Kassar Ph: 219-836-3349
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 317-783-8918
Iowa
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
Kansas
  Overland Park
 Menorah Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Hospital - South
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Prairie Village
 CCOP - Kansas City
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
Louisiana
  New Orleans
 Medical Center of Louisiana - New Orleans
 Robert W Veith Ph: 504-568-3410
  Email: aconne1@lsuhsc.edu
 Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
 Robert W Veith Ph: 504-568-3410
  Email: aconne1@lsuhsc.edu
 Tulane Cancer Center at Tulane University Hospital and Clinic
 William R. Robinson Ph: 504-988-6121
  Shreveport
 Feist-Weiller Cancer Center at Louisiana State University Health Sciences
 Robin A Lacour Ph: 318-813-1412
 Highland Clinic
 Manish Dhawan Ph: 318-798-4630
Maryland
  Elkton MD
 Union Hospital of Cecil County
 Mark E Borowsky Ph: 302-733-6227
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Duluth
 St. Luke's Hospital Cancer Care Center
 Tanya L. Repka Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Fergus Falls
 Lake Region Healthcare Corporation-Cancer Care
 Preston D. Steen Ph: 701-234-6161
Mississippi
  Jackson
 St. Dominic Cancer Center
 Donald P Seago Ph: 601-200-3300
Missouri
  Kansas City
 Heartland Hematology Oncology Associates, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 North Kansas City Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Research Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Cancer Institute at Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Luke's Hospital
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Lee's Summit
 Saint Luke's East - Lee's Summit
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Liberty
 Parvin Radiation Oncology
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
  Saint Joseph
 Heartland Regional Medical Center
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
 Saint Joseph Oncology, Incorporated
 Rakesh Gaur Ph: 913-948-5588
  Email: amy.krushelniski@hcahealthcare.com
Nebraska
  Kearney
 Good Samaritan Cancer Center at Good Samaritan Hospital
 Cynthia M. Lewis Ph: 308-865-7963
New Jersey
  Phillipsburg
 Women’s Institute for Gynecologic Cancer and Special Pelvic Surgery
 David Foster Silver Ph: 718-765-2500
New York
  New York
 New York University Medical Center
 Stephanie V. Blank Ph: 212-263-4434
  Email: prmc.coordinator@nyumc.org
North Carolina
  Rutherfordton
 Rutherford Hospital
 David Griffin Ph: 864-512-1000
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward J. Wos Ph: 701-323-5760
  Email: tfischer@mohs.org
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Eric L. Jenison Ph: 330-344-6041
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 317-783-8918
 David L. Rike Cancer Center at Miami Valley Hospital
 John W Moroney Ph: 937-208-2079
 Good Samaritan Hospital
 Howard M. Gross Ph: 317-783-8918
 Grandview Hospital
 Howard M. Gross Ph: 317-783-8918
 Samaritan North Cancer Care Center
 Howard M. Gross Ph: 317-783-8918
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 317-783-8918
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 317-783-8918
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 317-783-8918
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 317-783-8918
  Xenia
 Ruth G. McMillan Cancer Center at Greene Memorial Hospital
 Howard M. Gross Ph: 317-783-8918
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Tanja Pejovic Ph: 503-494-1080
  Email: trials@ohsu.edu
Pennsylvania
  Allentown
 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
 Richard M. Boulay Ph: 610-402-2273
South Carolina
  Anderson
 AnMed Cancer Center
 David Griffin Ph: 864-512-1000
Virginia
  Danville
 Danville Regional Medical Center
 Timothy W. Brotherton Ph: 434-793-0044
Washington
  Yakima
 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
 Sean F. Cleary Ph: 877-902-3324
Wisconsin
  Antigo
 Langlade Memorial Hospital
 Christopher G Peterson Ph: 877-405-6866
  Appleton
 Fox Valley Hematology and Oncology - East Grant Street
 Avi Bar-Lev Ph: 920-749-1171
  Chippewa Falls
 Marshfield Clinic - Chippewa Center
 Anthony C. Evans Ph: 715-389-4457
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Anthony C. Evans Ph: 715-389-4457
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Marshfield
 Marshfield Clinic - Marshfield Center
 Anthony C. Evans Ph: 715-389-4457
  Milwaukee
 Aurora Sinai Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Minocqua
 Marshfield Clinic - Lakeland Center
 Anthony C. Evans Ph: 715-389-4457
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Zahid N Dar Ph: 800-252-2990
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Anthony C. Evans Ph: 715-389-4457
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Anthony C. Evans Ph: 715-389-4457
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Anthony C. Evans Ph: 715-389-4457
  Summit
 Aurora Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Christopher G Peterson Ph: 877-405-6866
  Weston
 Diagnostic and Treatment Center
 Anthony C. Evans Ph: 715-389-4457
 Marshfield Clinic - Weston Center
 Anthony C. Evans Ph: 715-389-4457
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Anthony C. Evans Ph: 715-389-4457

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01167712
ClinicalTrials.gov processed this data on September 30, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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