Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227734
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-09-26
Brief Title:
Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer A Randomized Multicenter Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 capecitabine and oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Monoclonal antibodies such as cetuximab 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 Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer
PURPOSE This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery
PURPOSE This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer
Compare the objective response complete and partial response in patients treated with these regimens
Secondary
Compare the safety of these regimens in these patients
Compare the clinical benefit complete response partial response or stable disease for at least 18 weeks in patients treated with these regimens
Compare overall survival time to progression and time to treatment failure in patients treated with these regimens
OUTLINE This is a multicenter randomized study Patients are stratified according to performance status 0 vs 1 type of metastases synchronous vs metachronous prior adjuvant chemotherapy yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1
Arm II Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
In both arms courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients will be followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 74 patients 37 per treatment arm will be accrued for this study within 15 years
Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer
Compare the objective response complete and partial response in patients treated with these regimens
Secondary
Compare the safety of these regimens in these patients
Compare the clinical benefit complete response partial response or stable disease for at least 18 weeks in patients treated with these regimens
Compare overall survival time to progression and time to treatment failure in patients treated with these regimens
OUTLINE This is a multicenter randomized study Patients are stratified according to performance status 0 vs 1 type of metastases synchronous vs metachronous prior adjuvant chemotherapy yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1
Arm II Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
In both arms courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients will be followed every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 74 patients 37 per treatment arm will be accrued for this study within 15 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-20525 | None | None | None |