Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003594
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum
Status:
COMPLETED
Status Verified Date:
2020-04
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 Combining more than one drug may kill more tumor cells It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced recurrent or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy
PURPOSE Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced recurrent or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy
Detailed Description:
OBJECTIVES
Compare the time to progression in patients with locally advanced locally recurrent or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin fluorouracil leucovorin calcium and irinotecan
Compare the quality of life response rate time to treatment failure and overall survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOG performance status 0-1 vs 2 prior adjuvant chemotherapy yes vs no prior immunotherapy yes vs no and age under 65 vs 65 and over Patients are randomized to one of three treatment arms
Only arm II remains open to accrual
Arm I Saltz regimen Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest Courses repeat every 6 weeks Arm I closed to accrual as of March 15 2002
Arm II FOLFOX4 regimen Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2 Courses repeat every 2 weeks
Arm III oxaliplatin plus irinotecan Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1 Courses repeat every 3 weeks Arm III closed to accrual as of March 15 2002 Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before treatment during treatment arm specific and after completion of treatment
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 825 patients 275 per arm have been accrued for this study thus far Additional patients are being accrued on arm II Arms I and III closed to accrual as of March 15 2002
Compare the time to progression in patients with locally advanced locally recurrent or metastatic colorectal adenocarcinoma treated with combinations of oxaliplatin fluorouracil leucovorin calcium and irinotecan
Compare the quality of life response rate time to treatment failure and overall survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to ECOG performance status 0-1 vs 2 prior adjuvant chemotherapy yes vs no prior immunotherapy yes vs no and age under 65 vs 65 and over Patients are randomized to one of three treatment arms
Only arm II remains open to accrual
Arm I Saltz regimen Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest Courses repeat every 6 weeks Arm I closed to accrual as of March 15 2002
Arm II FOLFOX4 regimen Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2 Courses repeat every 2 weeks
Arm III oxaliplatin plus irinotecan Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on day 1 Courses repeat every 3 weeks Arm III closed to accrual as of March 15 2002 Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before treatment during treatment arm specific and after completion of treatment
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 825 patients 275 per arm have been accrued for this study thus far Additional patients are being accrued on arm II Arms I and III closed to accrual as of March 15 2002
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| CAN-NCIC-CO13 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066665 | REGISTRY | None | None |