Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066274
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2003-08-06
Brief Title:
Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
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
Status Verified Date:
2021-02
Last Known Status:
None
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 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20233 | None | None | None |
| FRE-FNCLCC-ACCORD-080103 | None | None | None |