Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
RATIONALE: 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. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer|
- Time to Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Response Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]Overall Response (OR) = CR + PR.
- Median Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Number of participants with an adverse event.
Please refer to the adverse event reporting for more detail.
|Study Start Date:||July 2004|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
|Biological: bevacizumab Drug: capecitabine|
- Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.
- Determine the response rate in patients treated with this regimen.
- Determine the median survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107315
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Marwan Fakih, MD||Roswell Park Cancer Institute|