Fluorouracil and Leucovorin With or Without Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Phase II Study Of Bolus/Infusion 5-FU/LV (de Gramont Regimen) Versus Oxaliplatin And Bolus/Infusion 5-FU/LV (de Gramont Regimen) As Third-Line Treatment Of Patients With Metastatic Colorectal Carcinoma |
| Study Start Date: | May 2001 |
| Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the colon or rectum Metastatic/recurrent disease not amenable to potentially curative therapy (e.g., inoperable metastatic disease) Documented sequential disease progression (by CT scan or MRI) after 2 prior chemotherapy regimens for metastatic/recurrent disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional CT scan or MRI OR At least 10 mm by spiral CT scan Must have received prior fluorouracil (or capecitabine) and leucovorin calcium with or without irinotecan as first-line therapy and irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium as second-line therapy for metastatic disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if documented liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if documented liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia No unstable angina No myocardial infarction within the past 6 months Pulmonary: No interstitial pneumonia No extensive and symptomatic fibrosis of the lung Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No known peripheral neuropathy (absence of deep tendon reflexes as the sole neurologic abnormality allowed) No diabetes or active infection No known dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior anticancer biologic therapy Chemotherapy: See Disease Characteristics No prior oxaliplatin No prior adjuvant irinotecan Prior adjuvant fluorouracil and leucovorin calcium allowed At least 3 weeks since prior chemotherapy (e.g., second-line irinotecan with or without fluorouracil (or capecitabine) and leucovorin calcium) for metastatic disease and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesion unless documented progression within the radiation portal Surgery: See Disease Characteristics At least 4 weeks since prior surgery for primary tumor or metastases and recovered Other: No prior investigational anticancer drug No other concurrent investigational agents
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Arizona Clinical Research Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| Arkansas Cancer Clinic, P.A. | |
| Pine Bluff, Arkansas, United States, 71603 | |
| United States, California | |
| Citrus Valley Medical Center | |
| Covina, California, United States, 92807 | |
| Cancer Center and Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010-3000 | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| Comprehensive Cancer Centers of the Desert | |
| Palm Springs, California, United States, 92262 | |
| Kaiser Permanente-Southern California Permanente Medical Group | |
| San Diego, California, United States, 92120 | |
| Kaiser Permanente Medical Center - Vallejo | |
| Vallejo, California, United States, 94589 | |
| John Muir Medical Center | |
| Walnut Creek, California, United States, 94598 | |
| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Northwestern Connecticut Oncology-Hematology Associates | |
| Torrington, Connecticut, United States, 06790 | |
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Center for Hematology-Oncology | |
| Boca Raton, Florida, United States, 33486 | |
| Halifax Medical Center | |
| Daytona Beach, Florida, United States, 32114 | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Hematology/Oncology Associates | |
| Jacksonville, Florida, United States, 32216 | |
| Lake Heart and Cancer Medical Center | |
| Leesburg, Florida, United States, 34748 | |
| Oncology-Hematology Group of South Florida | |
| Miami, Florida, United States, 33176 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| Hematology/Oncology Associates | |
| Port Saint Lucie, Florida, United States, 34952 | |
| United States, Illinois | |
| Northwest Medical Specialists, P.C. | |
| Arlington Heights, Illinois, United States, 60004 | |
| Dreyer Medical Clinic | |
| Aurora, Illinois, United States, 60506 | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Cancer Care Specialists of Central Illinois, S.C. | |
| Decatur, Illinois, United States, 62526 | |
| United States, Indiana | |
| Hope Center | |
| Terre Haute, Indiana, United States, 47809 | |
| United States, Iowa | |
| Medical Oncology and Hematology Associates | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center | |
| Mason City, Iowa, United States, 50401 | |
| United States, Kentucky | |
| Lucille Parker Markey Cancer Center, University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0093 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Baton Rouge General Medical Center | |
| Baton Rouge, Louisiana, United States, 70821-2511 | |
| Cancer and Blood Institute | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Massachusetts | |
| Saints Memorial Medical Center | |
| Lowell, Massachusetts, United States, 01852 | |
| United States, Michigan | |
| Saint Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Mississippi | |
| Medical Oncology Group | |
| Gulfport, Mississippi, United States, 39501 | |
| Jackson Oncology Associates, PLLC | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| St. Joseph Oncology, Inc. | |
| Saint Joseph, Missouri, United States, 64506 | |
| United States, Montana | |
| Deaconess Billings Clinic | |
| Billings, Montana, United States, 59107-5100 | |
| United States, New Jersey | |
| Monmouth Medical Center | |
| Long Branch, New Jersey, United States, 07740-6395 | |
| Jersey Shore Cancer Center | |
| Neptune, New Jersey, United States, 07753 | |
| Central Jersey Oncology Center | |
| New Brunswick, New Jersey, United States, 08901 | |
| Hematology Associates of New Jersey, P.A. | |
| Ridgewood, New Jersey, United States, 07450 | |
| Monmouth Hematology-Oncology Associates, P.A. | |
| West Long Branch, New Jersey, United States, 07764 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research & Treatment Center | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| Albert Einstein Comprehensive Cancer Center | |
| Bronx, New York, United States, 10461 | |
| HemOnCare, P.C. | |
| Brooklyn, New York, United States, 11235 | |
| North Shore Hematology/Oncology Associates, P.C. | |
| East Setauket, New York, United States, 11733 | |
| Reddy Cancer Treatment Center | |
| Malone, New York, United States, 12953 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| South Shore Hematology Oncology Associates, P.C. | |
| Rockville Centre, New York, United States, 11570 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, Ohio | |
| Mid-Ohio Oncology/Hematology, Inc. | |
| Columbus, Ohio, United States, 43213 | |
| Hematology Oncology Consultants Inc | |
| Columbus, Ohio, United States, 43235 | |
| Lawrence M. Stallings Medical Practice | |
| Wooster, Ohio, United States, 44691 | |
| United States, Oklahoma | |
| Oklahoma Oncology Inc. | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Bend Memorial Clinic | |
| Bend, Oregon, United States, 97701 | |
| Salem Hospital Regional Cancer Center | |
| Salem, Oregon, United States, 97309-5014 | |
| United States, Pennsylvania | |
| Oncology Hematology of Lehigh Valley, P.C. | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Pennsylvania Oncology Hematology Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Rhode Island | |
| Lifespan: The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Tennessee | |
| Memorial Hospital Cancer Center - Chattanooga | |
| Chattanooga, Tennessee, United States, 37404 | |
| Family Cancer Center | |
| Collierville, Tennessee, United States, 38017 | |
| Baptist Regional Cancer Center | |
| Knoxville, Tennessee, United States, 37920 | |
| West Cancer Clinic | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Center for Oncology Research and Treatment, Medical City Hospital | |
| Dallas, Texas, United States, 75230 | |
| Cancer Therapy and Research Center | |
| San Antonio, Texas, United States, 78229 | |
| Scott and White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84112 | |
| Intermountain Hematology/Oncology Associates, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Washington | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109 | |
| Study Chair: | Richard A. Gams, MD | Prologue Research International |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00016198 History of Changes |
| Other Study ID Numbers: | CDR0000068606, PROLOGUE-EFC4760, SANOFI-EFC4760 |
| Study First Received: | May 6, 2001 |
| Last Updated: | December 18, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Leucovorin Levoleucovorin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013