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Clinical Trials (PDQ®)

  • First Published: 2/5/2007
  • Last Modified: 1/8/2012

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Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Irinotecan Hydrochloride, Oxaliplatin, and Capecitabine as First-Line Therapy in Patients With Metastatic or Unresectable Locally Advanced Small Bowel Adenocarcinoma

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCCTG-N0543
N0543, NCT00433550

Trial Description

Purpose:

Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

This phase II trial is studying how well giving irinotecan together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic or unresectable locally advanced small bowel cancer.

Eligibility:

Eligibility criteria include the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive a 1½-hour infusion of irinotecan and a 2-hour infusion of oxaliplatin on day 1. They will also receive capecitabine by mouth twice a day on days 2-15. Treatment may repeat every 3 weeks for as long as benefit is shown.

Before beginning treatment, patients will undergo blood sample collection for laboratory studies.

After finishing treatment, patients will be evaluated every 6 weeks for 2 years and periodically thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Robert McWilliams, MD, Protocol chair
Ph: 507-284-8432
Benjamin Marchello, MD, Protocol co-chair
Ph: 507-538-7623
Matthew Goetz, MD, Protocol co-chair
Ph: 507-538-7623
Email: goetz.matthew@mayo.edu
Aminah Jatoi, MD, Protocol co-chair
Ph: 507-538-7623

Trial Sites

U.S.A.
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip Stella, MD
Ph: 734-712-1000
Iowa
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Clinical Trials Office - Cedar Rapids Oncology Associates
Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah Wilbur
Ph: 319-398-6011
  Clive
 Medical Oncology and Hematology Associates - West Des Moines
 Robert Behrens
Ph: 515-875-9713
  Des Moines
 CCOP - Iowa Oncology Research Association
 Robert Behrens
Ph: 515-244-7586
888-244-6061
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Robert Behrens
Ph: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Robert Behrens
Ph: 515-643-8740
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert Behrens
Ph: 515-643-8206
888-221-4849
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Wender, MD, PhD
Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Wender, MD, PhD
Ph: 712-252-0088
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center
Ph: 517-265-0116
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Iron Mountain
 Dickinson County Healthcare System
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Jackson
 Foote Memorial Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Monroe
 Community Cancer Center of Monroe
 Rex Mowat
Ph: 734-242-7902
 Mercy Memorial Hospital - Monroe
 Rex Mowat
Ph: 734-240-8400
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Minnesota
  Burnsville
 Fairview Ridges Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Coon Rapids
 Mercy and Unity Cancer Center at Mercy Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Duluth
 CCOP - Duluth
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
 Duluth Clinic Cancer Center - Duluth
 Clinical Trials Office - Duluth Clinic Cancer Center - Duluth
Ph: 218-786-3308
 Miller - Dwan Medical Center
 Daniel Nikcevich, MD, PhD
Ph: 218-786-3625
  Edina
 Fairview Southdale Hospital
 Clinical Trials Office - Fairview Southdale Hospital
Ph: 612-625-3650
  Fridley
 Mercy and Unity Cancer Center at Unity Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Hutchinson
 Hutchinson Area Health Care
 Patrick Flynn, MD
Ph: 612-863-8585
  Maplewood
 HealthEast Cancer Care at St. John's Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
 Minnesota Oncology Hematology, PA - Maplewood
 Patrick Flynn, MD
Ph: 612-863-8585
  Minneapolis
 Hennepin County Medical Center - Minneapolis
 Clinical Trials Office - Hennepin County Medical Center - Minneapolis
Ph: 612-873-5911
 Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
 Clinical Trials Office - Virginia Piper Cancer Institute
Ph: 612-863-5654
  Robbinsdale
 Humphrey Cancer Center at North Memorial Outpatient Center
 Clinical Trials Office - Humphrey Cancer Center at North Memorial Outpatient Center
Ph: 763-520-1893
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Saint Louis Park
 CCOP - Metro-Minnesota
 Patrick Flynn, MD
Ph: 612-863-8585
 Park Nicollet Cancer Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Saint Paul
 United Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Shakopee
 St. Francis Cancer Center at St. Francis Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  St. Paul
 Regions Hospital Cancer Care Center
 Clinical Trials Office - Regions Hospital Cancer Care Center
Ph: 651-254-1517
  Stillwater
 Lakeview Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Waconia
 Ridgeview Medical Center
 Patrick Flynn, MD
Ph: 612-863-8585
  Willmar
 Willmar Cancer Center at Rice Memorial Hospital
 Patrick Flynn, MD
Ph: 612-863-8585
  Woodbury
 Minnesota Oncology Hematology, PA - Woodbury
 Patrick Flynn, MD
Ph: 612-863-8585
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
  Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Butte
 St. James Healthcare Cancer Care
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
 Sletten Cancer Institute at Benefis Healthcare
 Benjamin Marchello, MD
Ph: 406-238-6290
  Havre
 Northern Montana Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
  Helena
 St. Peter's Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290
  Kalispell
 Glacier Oncology, PLLC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Medical Oncology at KRMC
 Benjamin Marchello, MD
Ph: 406-238-6290
 Kalispell Regional Medical Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Clinical Trials Office - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Ph: 406-329-7029
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward Wos, DO
Ph: 701-323-5741
 Medcenter One Hospital Cancer Care Center
 Edward Wos, DO
Ph: 701-323-5741
 Mid Dakota Clinic, PC
 Clinical Trials Office - Mid Dakota Clinic, PC
Ph: 701-530-6950
 St. Alexius Medical Center Cancer Center
 Clinical Trials Office - St. Alexius Medical Center Cancer Center
Ph: 701-530-6950
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Clinical Trails Office - Altru Cancer Center at Altru Hospital
Ph: 701-780-6520
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex Mowat
Ph: 419-352-9498
  Elyria
 Community Cancer Center
 Rex Mowat
Ph: 440-324-0400
 Hematology Oncology Center
 Rex Mowat
Ph: 440-324-0401
  Lima
 Lima Memorial Hospital
 Rex Mowat
Ph: 419-228-3335
  Maumee
 Northwest Ohio Oncology Center
 Rex Mowat
Ph: 419-891-5600
 Rex Mowat
Ph: 419-891-5600
  Norwalk
 Fisher-Titus Medical Center
 Rex Mowat
Ph: 419-668-8101
800-589-3862
  Oregon
 St. Charles Mercy Hospital
 Rex Mowat
Ph: 419-696-7200
 Toledo Clinic - Oregon
 Rex Mowat
Ph: 419-691-4235
  Sandusky
 North Coast Cancer Care, Incorporated
 Rex Mowat
Ph: 419-626-9090
  Sylvania
 Flower Hospital Cancer Center
 Clinical Trials Office - Flower Hospital Cancer Center
Ph: 419-824-1842
  Tiffin
 Mercy Hospital of Tiffin
 Rex Mowat
Ph: 419-447-3130
  Toledo
 CCOP - Toledo Community Hospital
 Rex Mowat
Ph: 419-843-6147
 Medical University of Ohio Cancer Center
 Clinical Trials Office - Medical University of Ohio Cancer Center
Ph: 419-383-6583
 St. Anne Mercy Hospital
 Rex Mowat
Ph: 419-407-2663
 St. Vincent Mercy Medical Center
 Rex Mowat
Ph: 419-251-4515
 Toledo Clinic, Incorporated - Main Clinic
 Rex Mowat
Ph: 419-479-5605
 Toledo Hospital
 Clinical Trials Office - Toledo Hospital
Ph: 419-824-1842
  Wauseon
 Fulton County Health Center
 Clinical Trials Office - Fulton County Health Center
Ph: 419-330-2708
Pennsylvania
  Butler
 Butler Memorial Hospital
 Rex Mowat
Ph: 412-283-6666
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Richard Tenglin
Ph: 605-719-2360
Virginia
  Fredericksburg
 Fredericksburg Oncology, Incorporated
 Rex Mowat
Ph: 540-368-0500
Wisconsin
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 St. Mary's Hospital Medical Center - Green Bay
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
 St. Vincent Hospital Regional Cancer Center
 Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Clinical Trials Office - Holy Family Memorial Medical Center Cancer Care Center
Ph: 920-320-2749
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Sheboygan
 St. Nicholas Hospital
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Anthony Jaslowski, MD, FACP
Ph: 920-884-3135
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290

Registry Information
Official Title A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy for Advanced Small Bowel Adenocarcinoma
Trial Start Date 2007-05-11
Trial Completion Date 2008-09-17 (estimated)
Registered in ClinicalTrials.gov NCT00433550
Date Submitted to PDQ 2006-12-18
Information Last Verified 2012-01-08
NCI Grant/Contract Number CA25224

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