Hereditary nonpolyposis colorectal cancer |
Cancer Family Syndrome; Colon Cancer, Familial Nonpolyposis; Familial nonpolyposis colon cancer; HNPCC; Lynch Syndrome |
Clinical Trial: Phase III Study of Irinotecan and Cetuximab vs Irinotecan as Second-Line Treatment in Patients with Metastatic, EGFR-Positive Colorectal Cancer
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, EGFR-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Colorectal Cancer | Drug: cetuximab | Phase III |
MedlinePlus related topics: Colorectal Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 1300
Study start: April 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
- Histologically documented colorectal cancer which is EGFR-positive by IHC (may be based on archival samples) and is metastatic.
- Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
- Prior fluoropyrimidine-containing regimen (5-FU, capecitabine, or UFT), for the first-line treatment of metastatic disease.
Exclusion Criteria
- A serious uncontrolled medical disorder that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy
- Unresolved diarrhea, bowel obstruction or history of inflammatory bowel disease
- Known or documented brain metastases
Location and Contact Information
Alabama
University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, 35294, United States; Recruiting
Andres Forero-Torres, MD, Principal Investigator
Comprehensive Cancer Institute, Huntsville, Alabama, 35801, United States; Recruiting
John Waples, MD, Principal Investigator
Comprehensive Cancer Institute, Huntsville, Alabama, 35801, United States; Recruiting
John Waples, MD, Principal Investigator
Alaska
Providence Alaska Medical Center, Anchorage, Alaska, 99508, United States; Recruiting
Latha Subramanian, MD, Principal Investigator
Anchorage Oncology Centre, Anchorage, Alaska, 99508, United States; Recruiting
Latha Subramanian, MD, Principal Investigator
Katmai Oncology Group, Anchorage, Alaska, 99508, United States; Recruiting
Latha Subramanian, MD, Principal Investigator
Arizona
ACRC/Arizona Clinical Research Center, Tucson, Arizona, 85712, United States; Recruiting
Manuel Modiano, MD, Principal Investigator
Arkansas
Little Rock Hematology Oncology, Little Rock, Arkansas, 72205, United States; Recruiting
Brad Baltz, MD, Principal Investigator
Arkansas Cancer Center, Pine Bluff, Arkansas, 71603, United States; Recruiting
Omar Atiq, MD, Principal Investigator
Little Rock Hematology Oncology Associates, Little Rock, Arkansas, 72205, United States; Recruiting
Diane Wilder, MD, Principal Investigator
California
New Hope Cancer & Research, Inc., Pomona, California, 91767, United States; Recruiting
Vandana Agarwal, MD, Principal Investigator
California Cancer Care, Greenbrae, California, 95904, United States; Recruiting
Peter D Eisenberg, MD, Principal Investigator
Compassionate Cancer Care Medical, Fountain Valley, California, 92708, United States; Recruiting
Haresh S Jhangiani, MD, Principal Investigator
Stockton Hematology Oncology Medical Group, Stockton, California, 95204, United States; Recruiting
Aminder Mehdi, MD, Principal Investigator
South Valley Medical Plaza, Gilroy, California, 95020, United States; Recruiting
Ronald Yanagihara, MD, Principal Investigator
Pacific Shores Medical Group, Long Beach, California, 90813, United States; Recruiting
Simon Tchekmedyian, MD, Principal Investigator
Kenmar Research Institute, Los Angeles, California, 90057, United States; Recruiting
Peter Kennedy, MD, Principal Investigator
Cancer and Blood Institute of the Desert, Rancho Mirage, California, 92270, United States; Recruiting
Robert Lemon, MD, Principal Investigator
Comprehensive Blood and Cancer Center, Bakersfield, California, 93309, United States; Recruiting
Ravi Patel, MD, Principal Investigator
Medical Oncology Care Associates, Orange, California, 92868, United States; Recruiting
Birbal Bhaskar, MD, Principal Investigator
Kaiser Permanente Medical Center, Vallejo, California, 94589, United States; Recruiting
Louis Fehrenbacher, MD, Principal Investigator
Oncology Care Medical Associates, Montebello, California, 90640, United States; Recruiting
Ira Felman, MD, Principal Investigator
Oncology Care Medical Associates, San Grabiel, California, 91776, United States; Recruiting
Ira Felman, MD, Principal Investigator
Oncology Care Medical Associates, Whittier, California, 90602, United States; Recruiting
Ira Felman, MD, Principal Investigator
Kenmar Research Institute, LLC, Los Angeles, California, 90057, United States; Recruiting
Raul Mena, MD, Principal Investigator
Tower Hematology/Oncology, Los Angeles, California, 90048, United States; Recruiting
Barry Rosenbloom, MD, Principal Investigator
Colorado
Rocky Mountain Cancer Center-Midtown, Denver, Colorado, 80218, United States; Recruiting
Allen Cohn, MD, Principal Investigator
Connecticut
Bennett Cancer Center at Stamford Hospital, Stamford, Connecticut, 06902, United States; Recruiting
Salvatore Del Prete, MD, Principal Investigator
Bendheim Cancer Center, Greenwich, Connecticut, 06830, United States; Recruiting
Monica Leon 203-863-3705
Arthur Rosenberg, MD, Principal Investigator
Northwestern Connecticut Oncology/Hematology, Torrington, Connecticut, 06790, United States; Recruiting
Debra Brandt, MD, Principal Investigator
Yale University School of Medicine, New Haven, Connecticut, 06520, United States; Recruiting
Barbara Burtness, MD, Principal Investigator
Eastern CT Hematology Oncology Associates, Norwich, Connecticut, 06360, United States; Recruiting
Dinesh Kapur, MD, Principal Investigator
Florida
Florida Oncology Associates, Jacksonville, Florida, 32207, United States; Recruiting
Yousif Abubakr, MD, Principal Investigator
Pasco Hernando Oncology, North Port Richey, Florida, 34652, United States; Recruiting
Kapisthalam S Kumar, MD, Principal Investigator
Hematology & Medical Oncology of Southern Palm Beach County, Inc., Boynton Beach, Florida, 33435, United States; Recruiting
Roger Brito, MD, Principal Investigator
Hematology-Oncology Associates, Port Sainte Lucie, Florida, 34952, United States; Recruiting
Nicholas Iannotti, MD, Principal Investigator
University of Florida/Jacksonville, Jacksonville, Florida, 32209, United States; Recruiting
Troy Guthrie, Jr., MD, Principal Investigator
Lake Heart and Cancer Medical Center, Leesburg, Florida, 34748, United States; Recruiting
Lourdes Mathew, MD, Principal Investigator
Palm Beach Institute of Hematology & Oncology, Boynton Beach, Florida, 33435, United States; Recruiting
Eyal Meiri, MD, Principal Investigator
M.D. Anderson Cancer Center Orlando, Orlando, Florida, 32806, United States; Recruiting
Omar Kayaleh, MD, Principal Investigator
Space Coastal Medical Associates, Titusville, Florida, 32796, United States; Recruiting
Richard Levine, MD, Principal Investigator
Ocala Oncology Center, Ocala, Florida, 34474, United States; Recruiting
Thomas Cartwright, MD, Principal Investigator
Watson Clinic, LLP Center for Cancer Care & Research, Lakeland, Florida, 33805, United States; Recruiting
Luis Franco, MD, Principal Investigator
Jackson Memorial Hospital & Clinics, Miami, Florida, 33136, United States; Recruiting
Pasquale Benedetto, MD, Principal Investigator
Mayo Clinic Jacksonville, Jacksonville, Florida, 32224, United States; Recruiting
George Kim, MD, Principal Investigator
Lakeheart and Medical Center, Leesburg, Florida, 34748, United States; Recruiting
Lourdes Matthew, MD, Principal Investigator
Medical Oncology Hematology, Tampa, Florida, 33613, United States; Recruiting
Ron Schiff, MD, Principal Investigator
Lakeland Regional Cancer Center, Lakeland, Florida, 33805, United States; Recruiting
James Jakub, MD, Principal Investigator
Georgia
Pasco Hernando Oncology Associates, Brooksville, Georgia, 34613, United States; Recruiting
Raju Rao, MD, Principal Investigator
Peachtree Hematology and Oncology, Atlanta, Georgia, 30309, United States; Recruiting
Charles A Henderson, MD, Principal Investigator
Central Georgia Hematology and Oncology, Macon, Georgia, 31201, United States; Recruiting
Frederick Schnell, MD, Principal Investigator
Georgia Cancer Specialist, Tucker, Georgia, 30342, United States; Recruiting
Mansoor Saleh, MD, Principal Investigator
Coastal Hematology & Oncology, Savannah, Georgia, 31406, United States; Recruiting
Brian Kim, MD, Principal Investigator
Idaho
St. Luke's Mountain State Tumor Institute, Boise, Idaho, 83712, United States; Recruiting
Theodore Walters, MD, Principal Investigator
Illinois
Joliet Oncology Hematology Associates, Joliet, Illinois, 60435, United States; Recruiting
Sarode Pundaleeka, MD, Principal Investigator
Lutheran General Cancer Care Center, Park Ridge, Illinois, 60068, United States; Recruiting
Brian Samuels, MD, Principal Investigator
Edward Cancer Center, Naperville, Illinois, 60540, United States; Recruiting
Alexander Hantel, MD, Principal Investigator
Indiana
Oncology & Hematology Associates, Inc., Indianapolis, Indiana, 46227, United States; Recruiting
David Loesch, MD, Principal Investigator
Kansas
Kansas University Medical Center, Kansas City, Kansas, 66160, United States; Recruiting
Stephen Williamson, MD, Principal Investigator
Kansas City Oncology & Hematology Group, Lenexa, Kansas, 66214, United States; Recruiting
Robert Belt, MD, Principal Investigator
Kansas City Cancer Centers, Overland Park, Kansas, 66214, United States; Recruiting
Marcus Neubauer, MD, Principal Investigator
Louisiana
Hematology/Oncology Clinic, Baton Rouge, Louisiana, 70808, United States; Recruiting
Gerald Miletello, MD, Principal Investigator
Oncology and Hematology, Metairie, Louisiana, 70006, United States; Recruiting
Jane Gurtler, MD, Principal Investigator
Maryland
Greater Baltimore Medical Center, Baltimore, Maryland, 21204, United States; Recruiting
Marshall Levine, MD, Principal Investigator
Michigan
Cook Research Institute at Spectrum Health, Grand Rapids, Michigan, 49503, United States; Recruiting
Lawrence Pawl, MD, Principal Investigator
St. Joseph Mercy Hospital Cancer Care Center, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip Stella, MD, Principal Investigator
West Michigan Cancer Center, Kalamazoo, Michigan, 490007, United States; Recruiting
Raymond Lord, III, MD, Principal Investigator
Providence Cancer Center, Southfield, Michigan, 48075, United States; Recruiting
Anibal Drelichman, MD, Principal Investigator
Minnesota
Hubert H. Humphrey Cancer Center, Robbinsdale, Minnesota, 55422, United States; Recruiting
Ross Siemers, MD, Principal Investigator
Mississippi
North Mississippi Hematology & Oncology Associates, Ltd., Tupelo, Mississippi, 38801, United States; Recruiting
Christopher Croot, MD, Principal Investigator
Jackson Oncology Associates, Jackson, Mississippi, 39202, United States; Recruiting
Grace Shumaker, MD, Principal Investigator
Missouri
Bond Clinic, Rolla, Missouri, 65401, United States; Recruiting
Joseph C Bond, MD, Principal Investigator
Capital Comprehensive Cancer Care Clinic, Jefferson City, Missouri, 65109, United States; Recruiting
Ali Khojasteh, MD, Principal Investigator
Washington University Medical Center, St. Louis, Missouri, 63110, United States; Recruiting
Joel Picus, MD, Principal Investigator
New York
Hemoncare, Brooklyn, New York, 11235, United States; Recruiting
Fakhuiddin Ahmed, MD, Principal Investigator
New York Oncology Hematology, Latham, New York, 12148, United States; Recruiting
Siddique Tai, MD, Principal Investigator
New York Oncology Hematology, Latham, New York, 12110, United States; Recruiting
Charles Weissman, MD, Principal Investigator
New York Oncology Hematology, Albany, New York, 12208, United States; Recruiting
Lawrence E Garbo, MD, Principal Investigator
Our Lady of Mercy Medical Center, Bronx, New York, 10466, United States; Recruiting
Sandeep Malik, MD, Principal Investigator
Stony Brook University Hospital, Stony Brook, New York, 11794, United States; Recruiting
Stefan Madejewicz, MD, Principal Investigator
School of Medicine, New York University, New York, New York, 10016, United States; Recruiting
Howard Hochster, MD, Principal Investigator
New York Medical College/Westchester, Valhalla, New York, 10595, United States; Recruiting
Hoo Chun, MD, Principal Investigator
North Shore Hematology/Oncology Associates, P.C., East Setauket, New York, 11733, United States; Recruiting
Brian Samuels, MD, Principal Investigator
Winthrop University Hospital, Mineola, New York, 11501, United States; Recruiting
Harry Staszewski, MD, Principal Investigator
North Shore Hematology/Oncology, East Setauket, New York, 11733, United States; Recruiting
Edward Samuel, MD, Principal Investigator
North Carolina
Raleigh Hematology Oncology Associates, Raleigh, North Carolina, 27609, United States; Recruiting
Margaret Deutsch, MD, Principal Investigator
Wake Forest University Baptist Medical Center, Winston Salem, North Carolina, 27157, United States; Recruiting
Coty Ho, MD, Principal Investigator
North Dakota
St. Alexius Medical Center, Mid Dakota, Bismark, North Dakota, 58501, United States; Recruiting
Bipinkumar Amin, MD, Principal Investigator
Ohio
Hematology Oncology Consultants, Columbus, Ohio, 43235, United States; Recruiting
Leslie R Laufman, MD, Principal Investigator
Hematology Oncology Consultants Inc, Newark, Ohio, 43055, United States; Recruiting
Charalampos Spirdonidis, MD, Principal Investigator
Dayton Clinical Oncology Program, Dayton, Ohio, 45429, United States; Recruiting
Howard Gross, MD, Principal Investigator
Alliance Cancer Center, Dayton, Ohio, 45459, United States; Recruiting
Stuart Merl, MD, Principal Investigator
Barrett Cancer Center University of Cincinnati, Cincinnati, Ohio, 45267, United States; Recruiting
Abdul Jazieh, MD, Principal Investigator
Pennsylvania
Hershey Medical Center, Hershey, Pennsylvania, 17033, United States; Recruiting
Alan Lipton, MD, Principal Investigator
Pennsylvania Oncology/Hematology Associates, Philadelphia, Pennsylvania, 19106, United States; Recruiting
Bernard Mason, MD, Principal Investigator
Central Pennsylvania Hematology & Medical Oncology Associates, P.C., Lemoyne, Pennsylvania, 17043, United States; Recruiting
John Conroy, MD, Principal Investigator
South Carolina
Charleston Cancer Center, Charleston, South Carolina, 29406, United States; Recruiting
William Schmidt, MD, Principal Investigator
Tennessee
Thompson Cancer Survival Center, Knoxville, Tennessee, 37916, United States; Recruiting
Samuel McCachren, Jr., MD, Principal Investigator
The West Clinic, P.C., Memphis, Tennessee, 38120, United States; Recruiting
Lee Schwartzberg, MD, Principal Investigator
Texas
Center for Oncology Research and Treatment, Dallas, Texas, 75230, United States; Recruiting
Barry Mirtsching, MD, Principal Investigator
Lone Star Oncology Consultants, Austin, Texas, 78759, United States; Recruiting
John Costanzi, MD, Principal Investigator
Scott & White Memorial Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD, Principal Investigator
North Texas Regional Cancer Center, Plano, Texas, 75075, United States; Recruiting
Charles Connor, MD, Principal Investigator
Southwest Regional Cancer Center, Austin, Texas, 78705, United States; Recruiting
Robert Kerr, MD, Principal Investigator
Texas Oncology, PA-Medical City, Dallas, Texas, 75230, United States; Recruiting
Michael Savin, MD, Principal Investigator
UT M.D. Anderson Cancer Center, Houston, Texas, 77030, United States; Recruiting
Cathy Eng, MD, Principal Investigator
Utah
Northern Utah Hematology and Oncology, Ogden, Utah, 84403, United States; Recruiting
Vincent Hansen, MD, Principal Investigator
Virginia
Danville Hematology and Oncology, Danville, Virginia, 24541, United States; Recruiting
Timothy W Brotherton, MD PhD, Principal Investigator
Arlington-Fairfax Hematology Oncology, Arlington, Virginia, 22205, United States; Recruiting
Robert Meister, MD, Principal Investigator
Virginia Oncology Associates, Newport News, Virginia, 23606, United States; Recruiting
Joseph Schulz, MD, Principal Investigator
Virginia Oncology Associates, Norfolk, Virginia, 23502, United States; Recruiting
Paul Conkling, MD, Principal Investigator
Washington
Cancer Care Northwest-North, Spokane, Washington, 99218, United States; Recruiting
Stephen Anthony, MD, Principal Investigator
Southwest Washington Medical Center, Vancouver, Washington, 98664, United States; Recruiting
Rakesh Gaur, MD, Principal Investigator
Medical Oncology Associates, Spokane, Washington, 99208, United States; Recruiting
Arvind Chaudhry, MD, Principal Investigator
St. Mary Medical Center St. Mary Regional Cancer Center, Walla Walla, Washington, 99362, United States; Recruiting
Robert Quackenbush, MD, Principal Investigator
Wisconsin
UW Cancer Center Wausau Hospital, Wausau, Wisconsin, 54401, United States; Recruiting
Harish Ahuja, MD, Principal Investigator
St. Vincent Hospital, Green Bay, Wisconsin, 54301, United States; Recruiting
James McGovern, MD, Principal Investigator
Froedtert Memorial Lutheran Hospital/Clinic, Milwaukee, Wisconsin, 53226, United States; Recruiting
Paul Ritch, MD, Principal Investigator
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, 53792, United States; Recruiting
Daniel Mulkerin, MD, Principal Investigator
More Information
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: June 20, 2003
ClinicalTrials.gov Identifier: NCT00063141
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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