A Multicenter, Open-Label, Randomized, Two-Arm Study of Irinotecan (CPT-11) Versus the Combination of Oxaliplatin + Irinotecan (CPT-11) as Second-Line Treatment of Metastatic Colorectal Carcinoma
OBJECTIVES:
- Compare the overall survival of patients with metastatic colorectal cancer treated with
irinotecan with or without oxaliplatin.
- Compare the response rate, time to tumor-related worsening of symptoms, time to disease
progression, onset and duration of responses, and duration of disease stabilization in
these patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs
involved (1 vs 2 or more), lactic dehydrogenase (no greater than 1.5 times upper limit of
normal (ULN) vs greater than 1.5 times ULN), and prior fluorouracil chemotherapy (adjuvant
vs first-line treatment for metastatic disease). Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive irinotecan IV over 90 minutes on day 1.
- Arm II: Patients receive oxaliplatin IV over 120 minutes followed by irinotecan IV over
30 minutes on day 1.
Courses repeat in each arm every 3 weeks for 1 year in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 30 days, every 4 weeks for 3 months, and then every 3 months
thereafter.
PROJECTED ACCRUAL: A total of 596 patients (298 per arm) will be accrued for this study
within 18 months.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Daniel G. Haller, MD
Study Chair
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
CDR0000068524
NCT00012389
December 2000
Name | Location |
---|---|
George Washington University Medical Center | Washington, District of Columbia 20037 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Baptist Regional Cancer Center - Knoxville | Knoxville, Tennessee 37901 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Whittingham Cancer Center | Norwalk, Connecticut 06856 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
New York Medical College | Valhalla, New York 10595 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
Lifespan: The Miriam Hospital | Providence, Rhode Island 02906 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Great Falls Clinic | Great Falls, Montana 59405 |
California Cancer Care, Inc. | Greenbrae, California 94904-2007 |
Hematology Oncology Consultants Inc | Columbus, Ohio 43235 |
Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
North Idaho Cancer Center | Coeur d'Alene, Idaho 83814 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Somerset Medical Center | Somerville, New Jersey 08876 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Oncology-Hematology Group of South Florida | Miami, Florida 33176 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Oncology Center at Providence Park | Mobile, Alabama 36608 |
Colorado Permanente Medical Group, P.C. | Denver, Colorado 80205 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northwest Medical Specialists, P.C. | Arlington Heights, Illinois 60004 |
Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
Lone Star Oncology | Austin, Texas 78759 |
University of Florida Health Science Center - Jacksonville | Jacksonville, Florida 32209 |
Pinnacle Health Hospitals | Harrisburg, Pennsylvania 17105-8700 |
UW Cancer Center Wausau Hospital | Wausau, Wisconsin 54401 |
Cancer Care Center | New Albany, Indiana 47150 |
Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Lakeland Regional Medical Center | Lakeland, Florida 33804 |
Baton Rouge General Medical Center | Baton Rouge, Louisiana 70821-2511 |
Norton Healthcare Pavilion | Louisville, Kentucky 40202 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Siteman Cancer Center | Saint Louis, Missouri 63110 |
Jackson Oncology Associates, PLLC | Jackson, Mississippi 39202 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Stanley Scott Cancer Center | New Orleans, Louisiana 70112 |
Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton, Florida 33428 |
Hematology/Oncology Associates | Port Saint Lucie, Florida 34952 |
Tower Hematology Oncology Medical Group | Los Angeles, California 90048 |
Raleigh Hematology/Oncology Associates - Wake Practice | Raleigh, North Carolina 27609 |
Center for Oncology Research and Treatment, Medical City Hospital | Dallas, Texas 75230 |
Memphis Cancer Center | Memphis, Tennessee 38119 |
Abington Hematology Oncology Associates, Incorporated | Abington, Pennsylvania 19001 |
Center for Hematology-Oncology | Boca Raton, Florida 33486 |
Southeast Florida Hematology-Oncology Group | Fort Lauderdale, Florida 33308 |
Erlanger Health Systems | Chattanooga, Tennessee 37403 |
Medical Oncology Care Associates | Orange, California 92668 |
P.M.K. Medical Group, Inc. | Oxnard, California 93030 |
Oncology & Hematology Associates of West Broward | Tamarac, Florida 33321 |
Hematology and Oncology Consultants | Titusville, Florida 32796 |
Dreyer Medical Clinic | Aurora, Illinois 60506 |
Northwestern Medical Faculty Foundation | Chicago, Illinois 60611 |
Parker Hughes Cancer Center | Roseville, Minnesota 55113 |
Missouri Cancer Care, P.C. | St. Charles, Missouri 63301 |
Baptist Health System Cancer Program | San Antonio, Texas 78205 |
Hematology-Oncology Associates of Frederiksburg, Inc. | Fredericksburg, Virginia 22401 |
Advanced Health Care | Milwaukee, Wisconsin 53209 |
Fountain Valley, California 92708 | |
Citrus Valley Medical Center | Covina, California 91722 |
Kenmar Research Institute | Los Angeles, California 90057 |
Hematology and Oncology Associates of Jacksonville | Jacksonville, Florida 32207 |
Lake Heart and Cancer Medical Center | Leesburg, Florida 34748 |
Hematology and Oncology Consultants, P.A. | Orlando, Florida 32804 |
University Community Hospital | Tampa, Florida 33613 |
Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
Veterans Affairs Medical Center - Louisville | Louisville, Kentucky 40206 |
Doctors Hospital of Jefferson | Metairie, Louisiana 70006 |
Medical Center of Boston | Boston, Massachusetts 02120 |
Berkshire Hematology Oncology, P.C. | Pittsfield, Massachusetts 01201 |
Flint, Michigan 48532 | |
Western Montana Clinic | Missoula, Montana 59807-7609 |
Queens Medical Associates, PC | Fresh Meadows, New York 11365 |
Queens Hospital Center | Jamaica, New York 11432 |
Piedmont Hematology-Oncology Associates | Winston-Salem, North Carolina 27103 |
Bend Memorial Clinic | Bend, Oregon 97701 |
Kaiser Permanente - Portland | Portland, Oregon 97227 |
Physicians East - Quadrangle | Greenville, South Carolina 27834 |
West Clinic | Memphis, Tennessee 38117 |
Tennessee Oncology, P.L.L.C. | Nashville, Tennessee 37205 |
Irving Cancer Center | Laramie, Wyoming 82070 |