Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008060
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Fluorouracil Oxaliplatin and Irinotecan Use and Sequencing A Randomized Trial to Assess the Role of Irinotecan and Oxaliplatin in Advanced Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2002-03
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 more effective for advanced colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil combined with leucovorin and either irinotecan or oxaliplatin in treating patients who have unresectable metastatic colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of fluorouracil combined with leucovorin and either irinotecan or oxaliplatin in treating patients who have unresectable metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of combination chemotherapy comprising fluorouracil 5-FU with leucovorin calcium CF and either irinotecan CPT-11 or oxaliplatin vs standard sequential single-agent therapy comprising 5-FU with CF followed by CPT-11 in patients with unresectable metastatic colorectal cancer
Determine whether combination chemotherapy is best used as first-line therapy or reserved for second-line therapy after progression on first-line single-agent therapy in these patients
Compare the efficacy and toxicity of an irinotecan-containing regimen vs an oxaliplatin-containing regimen in these patients
Compare the overall survival progression-free survival and quality of life of patients treated with these regimens
Compare the safety and toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to one of five treatment arms
Arm I standard therapy Patients receive first-line chemotherapy comprising leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 every 14 days Patients with progressive disease then receive second-line therapy comprising irinotecan IV over 90 minutes on day 1 every 21 days
Arm II Patients receive first-line chemotherapy as in arm I Patients with progressive disease then receive second-line therapy comprising irinotecan IV over 30 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2 every 14 days
Arm III Patients receive first-line chemotherapy comprising irinotecan leucovorin calcium and fluorouracil as in second-line therapy of arm II
Arm IV Patients receive first-line chemotherapy as in arm I Patients with progressive disease then receive second-line therapy comprising leucovorin calcium IV and oxaliplatin IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 every 14 days
Arm V Patients receive first-line chemotherapy comprising leucovorin calcium oxaliplatin and fluorouracil as in second-line therapy of arm IV
Treatment continues in all arms in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at weeks 6 and 12 and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 2100 patients 700 in arm I and 350 each in arms II-V will be accrued for this study
Compare the efficacy of combination chemotherapy comprising fluorouracil 5-FU with leucovorin calcium CF and either irinotecan CPT-11 or oxaliplatin vs standard sequential single-agent therapy comprising 5-FU with CF followed by CPT-11 in patients with unresectable metastatic colorectal cancer
Determine whether combination chemotherapy is best used as first-line therapy or reserved for second-line therapy after progression on first-line single-agent therapy in these patients
Compare the efficacy and toxicity of an irinotecan-containing regimen vs an oxaliplatin-containing regimen in these patients
Compare the overall survival progression-free survival and quality of life of patients treated with these regimens
Compare the safety and toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to one of five treatment arms
Arm I standard therapy Patients receive first-line chemotherapy comprising leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 every 14 days Patients with progressive disease then receive second-line therapy comprising irinotecan IV over 90 minutes on day 1 every 21 days
Arm II Patients receive first-line chemotherapy as in arm I Patients with progressive disease then receive second-line therapy comprising irinotecan IV over 30 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2 every 14 days
Arm III Patients receive first-line chemotherapy comprising irinotecan leucovorin calcium and fluorouracil as in second-line therapy of arm II
Arm IV Patients receive first-line chemotherapy as in arm I Patients with progressive disease then receive second-line therapy comprising leucovorin calcium IV and oxaliplatin IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 every 14 days
Arm V Patients receive first-line chemotherapy comprising leucovorin calcium oxaliplatin and fluorouracil as in second-line therapy of arm IV
Treatment continues in all arms in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at weeks 6 and 12 and then every 12 weeks thereafter
PROJECTED ACCRUAL A total of 2100 patients 700 in arm I and 350 each in arms II-V will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN79877428 | None | None | None |
| MRC-CR08-FOCUS | None | None | None |
| EU-20038 | None | None | None |