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| Sponsor: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075595 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: FOLFIRI regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer |
| Study Start Date: | June 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal adenocarcinoma
Meets 1 of the following criteria:
Progressive disease as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| France | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Centre Hospital Universitaire Hop Huriez | |
| Lille, France, 59037 | |
| Clinique Saint Jean | |
| Lyon, France, 69008 | |
| Hopital Saint Joseph | |
| Marseille, France, 13008 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95300 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Clinique Armoricaine De Radiologie | |
| Saint Brieuc, France, F-22015 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Centre Medico-Chirurgical Foch | |
| Suresnes, France, 92151 | |
| Investigator: | May Mabro, MD | Hopital Foch |
More Information
| ClinicalTrials.gov Identifier: | NCT00075595 History of Changes |
| Other Study ID Numbers: | CDR0000347378, FRE-GERCOR-FOLFIRI3-C00-2, EU-20333 |
| Study First Received: | January 9, 2004 |
| Last Updated: | January 3, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
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 Irinotecan Camptothecin 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 |