Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182715
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2005-09-15
Brief Title:
Combination Chemotherapy With or Without Cetuximab as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Velindre NHS Trust
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Three-Arm Randomised Controlled Trial Comparing Either Continuous Chemotherapy Plus Cetuximab or Intermittent Chemotherapy With Standard Continuous Palliative Combination Chemotherapy With Oxaliplatin and a Fluoropyrimidine in First Line Treatment of Metastatic Colorectal Cancer COIN
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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 It is not yet known whether combination chemotherapy and cetuximab are more effective than combination chemotherapy alone in treating colorectal cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone as first-line therapy in treating patients with metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with metastatic colorectal adenocarcinoma treated with continuous combination chemotherapy comprising oxaliplatin leucovorin calcium and fluorouracil OxMdG or oxaliplatin and capecitabine XELOX with vs without cetuximab vs intermittent combination chemotherapy with OxMdG or XELOX as first-line therapy
Secondary
Compare time of disease control and progression- and failure-free survival of patients treated with these regimens
Compare response in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the cost effectiveness of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a multicenter open label randomized controlled study Patients are randomized to 1 of 3 treatment arms
Arm I continuous chemotherapy Patients receive 1 of the following combination chemotherapy regimens of their choice or as per participating center
OxMdG Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
XELOX Patients receive 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
Arm II continuous chemotherapy and cetuximab Patients receive OxMdG or XELOX as in arm I Patients also receive cetuximab IV over 1-2 hours on days 1 and 8 for patients receiving OxMdG OR days 1 8 and 15 for patients receiving XELOX Treatment with OxMdG and cetuximab repeats every 14 days in the absence of disease progression or unacceptable toxicity Treatment with XELOX and cetuximab repeats every 21 days in the absence of disease progression or unacceptable toxicity
Arm III intermittent chemotherapy Patients receive OxMdG or XELOX as in arm I Treatment with OxMdG repeats every 14 days for up to 6 courses 12 weeks Treatment with XELOX repeats every 21 days for up to 4 courses 12 weeks Patients with disease progression after 12 weeks of therapy are removed from study treatment Patients with stable or responding disease after 12 weeks of therapy stop treatment and undergo clinical evaluation at least every 6 weeks treatment break until disease progression or clinical deterioration Upon evidence of disease progression or clinical deterioration patients restart treatment with OxMdG or XELOX as before and continue to alternate 12 weeks of treatment with treatment breaks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline 6 weeks 12 weeks and then every 12 weeks thereafter
After completion of study treatment patients are followed every 12 weeks for survival
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 2421 patients 807 per treatment arm will be accrued for this study within 35 years
Primary
Compare the overall survival of patients with metastatic colorectal adenocarcinoma treated with continuous combination chemotherapy comprising oxaliplatin leucovorin calcium and fluorouracil OxMdG or oxaliplatin and capecitabine XELOX with vs without cetuximab vs intermittent combination chemotherapy with OxMdG or XELOX as first-line therapy
Secondary
Compare time of disease control and progression- and failure-free survival of patients treated with these regimens
Compare response in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the cost effectiveness of these regimens in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a multicenter open label randomized controlled study Patients are randomized to 1 of 3 treatment arms
Arm I continuous chemotherapy Patients receive 1 of the following combination chemotherapy regimens of their choice or as per participating center
OxMdG Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
XELOX Patients receive 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
Arm II continuous chemotherapy and cetuximab Patients receive OxMdG or XELOX as in arm I Patients also receive cetuximab IV over 1-2 hours on days 1 and 8 for patients receiving OxMdG OR days 1 8 and 15 for patients receiving XELOX Treatment with OxMdG and cetuximab repeats every 14 days in the absence of disease progression or unacceptable toxicity Treatment with XELOX and cetuximab repeats every 21 days in the absence of disease progression or unacceptable toxicity
Arm III intermittent chemotherapy Patients receive OxMdG or XELOX as in arm I Treatment with OxMdG repeats every 14 days for up to 6 courses 12 weeks Treatment with XELOX repeats every 21 days for up to 4 courses 12 weeks Patients with disease progression after 12 weeks of therapy are removed from study treatment Patients with stable or responding disease after 12 weeks of therapy stop treatment and undergo clinical evaluation at least every 6 weeks treatment break until disease progression or clinical deterioration Upon evidence of disease progression or clinical deterioration patients restart treatment with OxMdG or XELOX as before and continue to alternate 12 weeks of treatment with treatment breaks in the absence of disease progression or unacceptable toxicity Quality of life is assessed at baseline 6 weeks 12 weeks and then every 12 weeks thereafter
After completion of study treatment patients are followed every 12 weeks for survival
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 2421 patients 807 per treatment arm will be accrued for this study within 35 years
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 |
|---|---|---|---|
| ISRCTN27286448 | None | None | None |
| UKM-MRC-COIN-CR10 | None | None | None |
| EUDRACT-2004-002951-16 | None | None | None |
| EU-20516 | None | None | None |