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S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery

Phase 2
Conditions
Colorectal Cancer
Registration Number
NCT00974389
Lead Sponsor
Osaka Medical College
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1, 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. Giving S-1 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works as third-line therapy in treating patients with colorectal cancer that is recurrent or that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

* To evaluate giving S-1 with bevacizumab to see how well it works as third-line therapy in KRAS-mutation patients with unresectable or recurrent colorectal cancer.

OUTLINE: Patients receive oral S-1 twice daily on days 1-28 and bevacizumab IV on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease-control rate
Secondary Outcome Measures
NameTimeMethod
Response rate
Overall survival
Safety
Progression-free survival

Trial Locations

Locations (1)

Osaka Medical College

🇯🇵

Takatsuki, Osaka, Japan

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