Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062426
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2003-06-05
Brief Title:
Oxaliplatin and Bevacizumab Avastin With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Prologue Research International
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Prospective Study Comparing Three Regimens Of Eloxatin Plus Fluoropyrimidine For Evaluation Of Safety And Tolerability In First Line Treatment Of Patients With Advanced Colorectal Cancer Tree Study
Status:
COMPLETED
Status Verified Date:
2004-04
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 such as oxaliplatin fluorouracil leucovorin and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them in different combinations may kill more tumor cells Monoclonal antibodies such as bevacizumab Avastin can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them It is not yet known which regimen works better in treating advanced colorectal cancer
PURPOSE This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer
PURPOSE This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES
Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin bevacizumab Avastin leucovorin calcium and fluorouracil or with oxaliplatin Avastin and capecitabine in patients with advanced colorectal cancer
Compare the overall response rate progression-free survival and time to treatment failure in patients treated with these regimens
Compare the composite toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive bevacizumab Avastin IV over 30-90 minutes oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil 5-FU IV over 46 hours beginning on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive Avastin IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm III Patients receive Avastin IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 3 months for at least 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 375 patients 125 per treatment arm will be accrued for this study
Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin bevacizumab Avastin leucovorin calcium and fluorouracil or with oxaliplatin Avastin and capecitabine in patients with advanced colorectal cancer
Compare the overall response rate progression-free survival and time to treatment failure in patients treated with these regimens
Compare the composite toxicity of these regimens in these patients
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive bevacizumab Avastin IV over 30-90 minutes oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil 5-FU IV over 46 hours beginning on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Arm II Patients receive Avastin IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Arm III Patients receive Avastin IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 1 month every 3 months for at least 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 375 patients 125 per treatment arm 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 |
|---|---|---|---|
| SANOFI-ARD5099 | None | None | None |
| PROLOGUE-SANOFI-ARD5099 | None | None | None |