Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070122
Status:
TERMINATED
Last Update Posted:
2013-01-25
First Post:
2003-10-03
Brief Title:
Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced Metastatic or Recurrent Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Modified FOLFOX6 Versus CAPOX With Bevacizumab NSC-704865 or Placebo as First-Line Therapy in Patients With Previously Untreated Advanced Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy such as oxaliplatin leucovorin fluorouracil and capecitabine work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab 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 Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES
I Compare overall survival in patients with locally advanced metastatic or recurrent colorectal cancer treated with fluorouracil leucovorin calcium oxaliplatin and bevacizumab vs capecitabine oxaliplatin and bevacizumab
II Compare progression-free survival and time to treatment failure in patients treated with these regimens
III Compare the response of patients with measurable disease treated with these regimens
IVCompare toxicity rates of these regimens in these patients V Compare patient-reported functional status and convenience of therapy in patients treated with these regimens
VI Correlate germline polymorphisms of DNA repair eg ERCC-1 XRCC1 GST-P1 XPD and ribonucleotide reductase target enzymes eg thymidylate synthase dihydropyrimidine dehydrogenase and thymidine phosphorylase angiogenesis eg vascular endothelial growth factor and growth factors eg epithelial growth factor receptor with survival progression-free survival and toxicity from chemotherapy in patients treated with these regimens
VII Correlate tumor mRNA expression levels of similar DNA repair enzymes as well as enzymes involved in angiogenesis with survival and progression-free survival in patients treated with these regimensCorrelate tumor mRNA expression levels of similar target enzymes before treatment with survival progression-free survival and toxicity in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Zubrod performance status 0 or 1 vs 2 and prior adjuvant therapy yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1 Patients are further randomized to receive bevacizumab or placebo IV over 30-90 minutes on day 1 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity NOTE As of 111504 placebo is no longer part of treatment plan all patients receive bevacizumab
ARM II Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine on days 1-15 Patients are further randomized to receive bevacizumab or placebo as in arm I Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE As of 111504 placebo is no longer part of treatment plan all patients receive bevacizumab
Patients are followed every 3 months until disease progression After disease progression patients are followed every 6 months for 2 years and then annually for up to 4 years after study entry
PROJECTED ACCRUAL A total of 2200 patients 1100 per treatment arm will be accrued for this study within 3 years
I Compare overall survival in patients with locally advanced metastatic or recurrent colorectal cancer treated with fluorouracil leucovorin calcium oxaliplatin and bevacizumab vs capecitabine oxaliplatin and bevacizumab
II Compare progression-free survival and time to treatment failure in patients treated with these regimens
III Compare the response of patients with measurable disease treated with these regimens
IVCompare toxicity rates of these regimens in these patients V Compare patient-reported functional status and convenience of therapy in patients treated with these regimens
VI Correlate germline polymorphisms of DNA repair eg ERCC-1 XRCC1 GST-P1 XPD and ribonucleotide reductase target enzymes eg thymidylate synthase dihydropyrimidine dehydrogenase and thymidine phosphorylase angiogenesis eg vascular endothelial growth factor and growth factors eg epithelial growth factor receptor with survival progression-free survival and toxicity from chemotherapy in patients treated with these regimens
VII Correlate tumor mRNA expression levels of similar DNA repair enzymes as well as enzymes involved in angiogenesis with survival and progression-free survival in patients treated with these regimensCorrelate tumor mRNA expression levels of similar target enzymes before treatment with survival progression-free survival and toxicity in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Zubrod performance status 0 or 1 vs 2 and prior adjuvant therapy yes vs no Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46-48 hours beginning on day 1 Patients are further randomized to receive bevacizumab or placebo IV over 30-90 minutes on day 1 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity NOTE As of 111504 placebo is no longer part of treatment plan all patients receive bevacizumab
ARM II Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine on days 1-15 Patients are further randomized to receive bevacizumab or placebo as in arm I Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity NOTE As of 111504 placebo is no longer part of treatment plan all patients receive bevacizumab
Patients are followed every 3 months until disease progression After disease progression patients are followed every 6 months for 2 years and then annually for up to 4 years after study entry
PROJECTED ACCRUAL A total of 2200 patients 1100 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000330000 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0303 | None | None | None |
| U10CA032102 | NIH | None | None |