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Combination Chemotherapy in Treating Patients With Recurrent 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: NCT00003260
  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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer

PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.


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

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, Randomized
Official Title:   Multicentre Phase III Comparing To Therapeutic Sequence: Folfiri Following of Folfox6 (Group A) and Folfox6 Following Of (Group B) For Metastatic Colorectal Cancer

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

Estimated Enrollment:   109
Study Start Date:   January 1998

Detailed Description:

OBJECTIVES: I. Compare the efficacy of leucovorin calcium plus fluorouracil with either irinotecan or oxaliplatin in terms of progression free survival in patients with recurrent metastatic colorectal cancer. II. Compare the efficacy, tolerance, quality of life, and overall survival in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution and measurable or evaluable disease. Patients are randomized to receive either a 2 hour continuous infusion of irinotecan or a 2 hour continuous infusion of oxaliplatin on day 1. All patients receive a 2 hour continuous infusion of leucovorin calcium followed by IV bolus and 48 hour continuous infusion of fluorouracil on days 1 and 2. Courses are repeated every 2 weeks. Patients will receive the alternate treatment if disease progression or unacceptable toxicity occurs on their initial treatment. Patients are followed every 3 months after end of treatment.

PROJECTED ACCRUAL: This study will accrue a total of 109 patients per arm over approximately 18 months.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven recurrent stage IV adenocarcinoma of the colon and rectum No CNS metastases Bidimensionally measurable lesion (at least 2 cm in dimension) or evaluable disease (as malignant ascites or bone metastases) as documented by CT or MRI Must be outside prior radiotherapy field

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Alkaline phosphatase no greater than 3 times normal SGOT/SGPT no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled congestive heart failure or angina pectoris in the past 6 months No hypertension or arrhythmia in the past 6 months Neurologic: No peripheral neuropathy No significant neurologic or psychiatric disorder Other: No complete or partial obstruction of the bowel No serious nonmalignant disease No active infection No second malignancy except in situ cervical carcinoma or nonmelanomatous skin carcinoma No chronic diarrhea Not pregnant or nursing Fertile women must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy with no disease progression or after metastatic liver resection No prior chemotherapy with oxaliplatin or irinotecan Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since surgery Other: At least 30 days since use of investigational agent

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003260

Locations
France
Hopital Saint Antoine    
      Paris, France, 75571

Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators
Study Chair:     Aimery de Gramont, MD     Hopital Saint Antoine    
  More Information


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

Study ID Numbers:   CDR0000066151, FRE-GERCOR-C97-3/CPTF308, FRE-C97-3/CPTF301, FRE-C97-3/CPTF308, RP-FRE-C97-3/CPTF308, EU-97044
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003260
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 September 16, 2008




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