Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer

UMIN ID: UMIN000007072

Registered date:16/01/2012

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Metastatic colorectal cancer
• Date of first enrollment: 2009/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks. TS-1 80 mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks. Bevacizumab 7mg/kg is administered with 30-90 min intravenous injection on days 1, 15.

Outcome(s)

• Primary Outcome: Overall response rate
• Secondary Outcome: Overall survival Progression-free survival Toxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patients with pathologically proven colorectal cancer. 2) Patients with unrecectable metastatic colorectal cancer. 3) Patients with confirmed target lesion. 4) Patients with no prior chemotherapy. 5) Patients with no prior radiotherapy. 6) Patients of age =>20 and 75> 7) Patients with expected life for at least 3 month. 8) Performance Status:0-1(ECOG) 9) Sufficient organ functions 1:hemoglobin>=9.0g/dL 2:WBC >=3,500/mm3 and 12000/mm3> 3:neutrophils>=1,500/mm3 4:platelets>=100,000/mm3 5:total bilirubin <=1.5mg/dL 6: ALT AST<=100IU (or <=150IU if liver metastases were present) 7:serum creatinine <= 1.2mg/dL 8:creatinine clearance>=60ml/min 10) Capability of oral intake 11) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration 12) Written informed consent 1) Medical history of severe anaphylaxis or allergia to any drug 2) Patients with active synchronous or metachronous malignancy other than carcinoma in situ 3) Severe infection 4) Perforation of the digestive tract or paralyzed intestinal tract within 1 year of registration 5) Uncontrollable hypertension with medical therapy 6) Severe complication (lung fibrosis or intestinal pneumonia, heart failure, renal failure, hepatic insufficiency, uncontrolled diabetes etc) 7) Massive pleural or abdominal effusion 8) Watery diarrhea 9) Need to treatment with flucytosine or atazanavir sulfate 10) Patients with brain metastases 11) Pregnant or nursing 12) Severe mental illness 13) Systemic administration of corticosteroids 14) Patients with uric protein 2+ 15) Patients with thrombosis 16) Patients with cerebral infarction, cardiac infarction or pulmonary infarction 17) Patients who underwent surgery within 4 weeks 18) Systemic administration of antiplatelet drug 19) Patients with known bleeding disorders or clotting disorder 20) Patients who are judged inappropriate for the entry into the study by the investigator

Related Information

• Primary Sponsor: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
• Source(s) of Monetary Support: Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group