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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006115
  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: 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.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Irinotecan    Irinotecan hydrochloride    Fluorouracil    Oxaliplatin    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 1999

Detailed Description:

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.

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
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006115

Locations
France
American Hospital of Paris    
      Neuilly Sur Seine, France, F-92202
C.H. Senlis    
      Senlis, France, 60300
Centre Hospital Universitaire Hop Huriez    
      Lille, France, 59000
Centre Hospitalier de Mulhouse    
      Mulhouse, France, 68051
Centre Jean Bernard    
      Le Mans, France, 72000
CH Meulan    
      Meulan, France, 78250
CHU Pitie-Salpetriere    
      Paris, France, 75651
Clinique de l'Orangerie    
      Strasbourg, France, 67010
Polyclinique De Courlancy    
      Reims, France, F-51100
Hopital Bichat-Claude Bernard    
      Paris, France, 75018
Hopital Claude Gallien    
      Quincy Sous Senart, France, 91480
Hopital Drevon    
      Dijon, France, 21000
Hopital Saint Antoine    
      Paris, France, 75571
Hopital Tenon    
      Paris, France, 75970
Intercommunal Hospital    
      Montfermeil, France, 93370
Clinique Saint Jean    
      Lyon, France, 69008

Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators
Study Chair:     Mohamed Hebbar, MD     Centre Hospital Universitaire Hop Huriez    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068128, FRE-GERCOR-C98-3-FIREFOX, EU-20023
First Received:   August 3, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006115
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

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Irinotecan
Colonic Diseases
Leucovorin
Intestinal Diseases
Rectal Diseases
Camptothecin
Recurrence
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on August 21, 2008




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