Status:
UNKNOWN
S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery
Lead Sponsor:
Osaka Medical College
Conditions:
Colorectal Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
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...
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 rec...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00974389
Start Date
July 1 2009
Last Update
August 12 2013
Active Locations (1)
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1
Osaka Medical College
Takatsuki, Osaka, Japan, 569-8686