Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Biological: bevacizumab; Drug: capecitabine

• Registration Number: NCT00107315
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.

Secondary

* 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-04-05
• Study First Submitted QC: 2005-04-05
• Study First Posted: 2005-04-06
• Primary Completion: 2008-06
• Results First Submitted: 2014-01-08
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-03
• Results First Posted: 2014-07-04
• Last Update Posted: 2014-07-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	bevacizumab	Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
Arm 1	capecitabine	Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7

Primary Outcome Measures

Name	Time	Method
Time to Progression	1 year

Secondary Outcome Measures

Name	Time	Method
Median Survival	1 year
Response Rate	1 year	Overall Response (OR) = CR + PR.
Toxicity	1 year	Number of participants with an adverse event.; Please refer to the adverse event reporting for more detail.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States