Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 8:40 AM
Study NCT ID:
NCT00003260
Status:
UNKNOWN
Last Update Posted:
2009-01-13
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: