Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070213
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2003-10-03
Brief Title:
Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Medical Research Council
Organization:
Medical Research Council
Study Overview
Official Title:
Drug Treatment for Bowel Cancer Making the Best Choices When a Milder Treatment is Needed
Status:
COMPLETED
Status Verified Date:
2021-09
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 leucovorin fluorouracil capecitabine and oxaliplatin 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 whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer
PURPOSE This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer
PURPOSE This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare the progression-free survival of patients with metastatic colorectal adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without oxaliplatin or capecitabine with vs without oxaliplatin
Compare the quality of life of patients treated with these fluorouracil-based vs capecitabine-based regimens
Secondary
Compare the failure-free and overall survival of patients treated with these regimens
Compare the toxic effects and adverse events associated with these regimens in these patients
Compare the limited health assessments of patients treated with these regimens
Compare the health economics associated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms and receive 12 weeks of therapy
Arm I MdG regimen Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm II
Arm II OxMdG regimen Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study
Arm III Cap regimen Patients receive oral capecitabine twice daily on days 1-15 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm IV
Arm IV OxCap regimen Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study
All patients are then re-evaluated at least every 6 weeks and begin another 12 weeks of therapy at any evidence eg clinical radiological or tumor marker of disease progression Patients with chemo-sensitive disease may repeat alternating 12-week therapy sessions and evaluation periods indefinitely
Quality of life is assessed at baseline at 12-14 weeks at 24 weeks and then every 3 months thereafter
Patients are followed every 3 months
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 460 patients 115 per treatment arm will be accrued for this study within 2 years
Primary
Compare the progression-free survival of patients with metastatic colorectal adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without oxaliplatin or capecitabine with vs without oxaliplatin
Compare the quality of life of patients treated with these fluorouracil-based vs capecitabine-based regimens
Secondary
Compare the failure-free and overall survival of patients treated with these regimens
Compare the toxic effects and adverse events associated with these regimens in these patients
Compare the limited health assessments of patients treated with these regimens
Compare the health economics associated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 4 treatment arms and receive 12 weeks of therapy
Arm I MdG regimen Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm II
Arm II OxMdG regimen Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1 Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study
Arm III Cap regimen Patients receive oral capecitabine twice daily on days 1-15 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm IV
Arm IV OxCap regimen Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study
All patients are then re-evaluated at least every 6 weeks and begin another 12 weeks of therapy at any evidence eg clinical radiological or tumor marker of disease progression Patients with chemo-sensitive disease may repeat alternating 12-week therapy sessions and evaluation periods indefinitely
Quality of life is assessed at baseline at 12-14 weeks at 24 weeks and then every 3 months thereafter
Patients are followed every 3 months
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 460 patients 115 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| EU-20303 | None | None | None |
| NCRI-FOCUS2 | None | None | None |
| MRC-CR09 | None | None | None |