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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer  Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,adenocarcinoma of the rectum,adenocarcinoma of the colon,Stage 4 rectal cancer,recurrent rectal cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: 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: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.
Details: OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer. II. Evaluate these treatment regimens in terms of overall survival, response rate, toxicity, and quality of life in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic adenocarcinoma of the colon or rectum - Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases) - Failure after first line therapy; Fluorouracil and leucovorin calcium OR Raltitrexed; No oxaliplatin or irinotecan - Relapse within 6 months of adjuvant therapy - Relapse within 6 months of hepatic artery infusion chemotherapy for resected hepatic metastasis - No symptomatic brain metastasis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: At least 2 weeks since prior radiotherapy - Surgery: At least 2 weeks since prior surgery - Other: No other concurrent experimental drugs --Patient Characteristics-- - Age: 18 to 80 - Performance status: WHO 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3 - Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN); Alkaline phosphatase no greater than 5 times ULN - Renal: Not specified - Other: No bowel obstruction; No other significant, uncontrolled underlying medical or psychiatric condition; No serious active infection; Neurologically stable; No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix; No psychological, social, familial, or geographical condition that would preclude study; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
M.Hebbar, Study Chair, GERCOR
Polyclinique De Courlancy
Reims, , F-51100
France
Clinique Saint Jean
Lyon, , 69008
France
Centre Hospital Universitaire Hop Huriez
Lille, , 59000
France
Clinique de l'Orangerie
Strasbourg, , 67010
France
Centre Jean Bernard
Le Mans, , 72000
France
C.H. Senlis
Senlis, , 60300
France
Intercommunal Hospital
Montfermeil, , 93370
France
CHU Pitie-Salpetriere
Paris, , 75651
France
Hopital Claude Gallien
Quincy-sous-Senart, , 91480
France
Centre Hospitalier de Mulhouse
Mulhouse, , 68051
France
Hopital Saint Antoine
Paris, , 75571
France
American Hospital of Paris
Neuilly-sur-Seine, , F-92202
France
Hopital Bichat-Claude Bernard
Paris, , 75018
France
Hopital Tenon
Paris, , 75970
France
Hopital Drevon
Dijon, , 21000
France
CH Meulan
Meulan, , 78250
France
Additional Information:
Study ID Numbers: CDR0000068128; FRE-GERCOR-C98-3-FIREFOX,EU-20023
Study Start Date: April 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006115
Other Stage 4 Colon Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
4. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients With Metastatic Colorectal Cancer
5. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Clinical Trials
Other Paris Clinical Trials
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
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