Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098787
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2004-12-08
Brief Title:
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Treatment Selection Based Upon Tumor Thymidylate Synthase Expression in Previously Untreated Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 irinotecan leucovorin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth Studying the amount of an enzyme found in the tumor may help doctors plan the best treatment
PURPOSE This randomized phase II trial is studying giving bevacizumab oxaliplatin and irinotecan or giving bevacizumab oxaliplatin leucovorin and fluorouracil in treating patients with metastatic or recurrent colorectal cancer
PURPOSE This randomized phase II trial is studying giving bevacizumab oxaliplatin and irinotecan or giving bevacizumab oxaliplatin leucovorin and fluorouracil in treating patients with metastatic or recurrent colorectal cancer
Detailed Description:
OBJECTIVES
Compare the response rate complete and partial progression-free survival and overall survival of patients with previously untreated metastatic or locally recurrent colorectal adenocarcinoma with high vs low thymidylate synthase TS expression treated with fluorouracil leucovorin calcium oxaliplatin and bevacizumab or irinotecan oxaliplatin and bevacizumab
Compare the toxicity of these regimens in these patients
Correlate gene expression with response rates in patients treated with these regimens
Correlate gene expression with toxicity of these regimens in these patients
Correlate dihydropyrimidine dehydrogenase thymidine phosphorylase and mammalian excision repair cross complementary protein expression with antitumor response in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to thymidylate synthase TS expression levels high vs low or indeterminate Patients with high TS expression are randomized to 1 of 2 treatment arms Arms A or B Patients with low or indeterminate TS expression are assigned to Arm C
Arm A Patients receive bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15
Arm B Patients receive bevacizumab and oxaliplatin as in arm A leucovorin calcium IV over 2 hours and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15
Arm C Patients receive bevacizumab oxaliplatin leucovorin calcium and fluorouracil as in arm B
In all arms courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Patients are followed up every 3 months for 2 years and then every 6 months for 2 years from the date of study registration
Compare the response rate complete and partial progression-free survival and overall survival of patients with previously untreated metastatic or locally recurrent colorectal adenocarcinoma with high vs low thymidylate synthase TS expression treated with fluorouracil leucovorin calcium oxaliplatin and bevacizumab or irinotecan oxaliplatin and bevacizumab
Compare the toxicity of these regimens in these patients
Correlate gene expression with response rates in patients treated with these regimens
Correlate gene expression with toxicity of these regimens in these patients
Correlate dihydropyrimidine dehydrogenase thymidine phosphorylase and mammalian excision repair cross complementary protein expression with antitumor response in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to thymidylate synthase TS expression levels high vs low or indeterminate Patients with high TS expression are randomized to 1 of 2 treatment arms Arms A or B Patients with low or indeterminate TS expression are assigned to Arm C
Arm A Patients receive bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15
Arm B Patients receive bevacizumab and oxaliplatin as in arm A leucovorin calcium IV over 2 hours and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15
Arm C Patients receive bevacizumab oxaliplatin leucovorin calcium and fluorouracil as in arm B
In all arms courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Patients are followed up every 3 months for 2 years and then every 6 months for 2 years from the date of study registration
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 |
|---|---|---|---|
| U10CA021115 | NIH | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| E4203 | OTHER | None | None |