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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Combination Chemotherapy With S-1 Plus Avastin in Unresectable or Recurrent Colorectal Cancer After Failure of Prior Chemotherapy, Including Irinotecan and Oxaliplatin Regimens.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Biological: bevacizumab
* Drug: tegafur-gimeracil-oteracil potassium


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma Inoperable, locally advanced, or metastatic disease KRAS-mutated Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer Measurable disease according to RECIST No moderate or severe ascites or pleural effusion requiring treatment No metastasis to the CNS PATIENT CHARACTERISTICS: ECOG performance status 0-2 White blood cell count > 3,500/mm³ but < 12,000/mm³ Neutrophil count > 1,500/mm³ Hemoglobin > 9.0 g/dL Platelet count > 100,000/mm³ Total bilirubin < 1.5 mg/dL AST and ALT < 100 U/L (< 200 U/L in patients with liver metastasis) Serum creatinine < 1.2 mg/dL Creatinine clearance ≥ 50 mL/min Urine dipstick for proteinuria < 1+ INR < 1.5 Not pregnant or nursing Able to take capsules orally No active second cancer No active infections (e.g., patients with pyrexia of ≥ 38°C) No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension) No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator No serious drug hypersensitivity or a history of drug allergy No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding No clinically significant traumatic injury within the past 4 weeks No severe mental disorder PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent low-dose aspirin therapy (< 325 mg/day) allowed More than 4 weeks since prior major surgical procedure or open biopsy No prior therapy radiotherapy No prior therapy with S-1 No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment. No concurrent continuous treatment with steroids No concurrent treatment with flucytosine

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: bevacizumab|nan|
|Drug: tegafur-gimeracil-oteracil potassium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-control rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Safety |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer