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Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003260
First received: November 1, 1999
Last updated: January 10, 2009
Last verified: May 2007

November 1, 1999
January 10, 2009
January 1998
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Complete list of historical versions of study NCT00003260 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Multicentre Phase III Comparing To Therapeutic Sequence: Folfiri Following of Folfox6 (Group A) and Folfox6 Following Of (Group B) For Metastatic Colorectal Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: FOLFIRI regimen
  • Drug: FOLFOX regimen
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
  • Drug: oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
109
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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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00003260
CDR0000066151, FRE-GERCOR-C97-3/CPTF308, FRE-C97-3/CPTF301, FRE-C97-3/CPTF308, RP-FRE-C97-3/CPTF308, EU-97044
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Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
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Study Chair: Aimery de Gramont, MD Hopital Saint Antoine
National Cancer Institute (NCI)
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP