Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00006115
Last Updated: 2009-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1999-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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FOLFIRI regimen
FOLFOX regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
oxaliplatin
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
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Mohamed Hebbar, MD
Role: STUDY_CHAIR
Centre Hospital Universitaire Hop Huriez
Locations
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Hopital Drevon
Dijon, , France
Centre Jean Bernard
Le Mans, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Clinique Saint Jean
Lyon, , France
CH Meulan
Meulan-en-Yvelines, , France
Intercommunal Hospital
Montfermeil, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
Hopital Bichat-Claude Bernard
Paris, , France
Hopital Saint Antoine
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Hopital Claude Gallien
Quincy-sous-Sénart, , France
Polyclinique De Courlancy
Reims, , France
C.H. Senlis
Senlis, , France
Clinique de l'Orangerie
Strasbourg, , France
Countries
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Other Identifiers
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FRE-GERCOR-C98-3-FIREFOX
Identifier Type: -
Identifier Source: secondary_id
EU-20023
Identifier Type: -
Identifier Source: secondary_id
CDR0000068128
Identifier Type: -
Identifier Source: org_study_id
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