NCT00066274

Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

Randomized Phase II Study Evaluating Three Chemotherapies: [Irinotecan + Oxaliplatin (Irinox)], [Irinotecan + LV5FU2] and [Oxaliplatin + LV5FU2] as First Intention Treatment in Subjects With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

Detailed description

OBJECTIVES: * Compare the efficacy, in terms of response rate (partial response and complete response), of irinotecan and oxaliplatin vs irinotecan, fluorouracil, and leucovorin calcium vs oxaliplatin, fluorouracil, and leucovorin calcium in patients with metastatic colorectal cancer. * Compare the progression-free survival of patients treated with these regimens. * Compare the tolerability of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1. * Arm II: Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. * Arm III: Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. In all arms, treatment repeats every 2 weeks for 26 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months for 1 year. Patients are followed at 2 months. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 1 year.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFIRI regimen
DRUG	FOLFOX regimen
DRUG	fluorouracil
DRUG	irinotecan hydrochloride
DRUG	leucovorin calcium
DRUG	oxaliplatin

Timeline

• Start date: 2002-07-23
• Primary completion: 2005-11-04
• Completion: 2007-04-01
• First posted: 2003-08-07
• Last updated: 2021-03-02

Locations

17 sites across 1 country: France