Phase II study of a combination of CPT-11 and S-1 and bevacizumab in patients with metastatic colon cancer.

UMIN ID: UMIN000001631

Registered date:14/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: metastatic colorectal cancer
• Date of first enrollment: 2009/01/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): We use three drugs (CPT-11, S-1, bevacizumab) for this trial. The treatment schedule of CPT-11 and bevacizumab are administrated on day 1 and day 15, and of S-1 is administrated between day1 and day 21. The dosage of CPT-11 are 75 mg/m2, and of S-1 are 65 mg (the dosage are calculated by body surface area), and of bevacizumab are 10 mg/kg.

Outcome(s)

• Primary Outcome: Progression Free Survival
• Secondary Outcome: Response Rate Overall survial Time to Treatment Failure Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: The exclusion criteria were as follows; patients were not eligible for this study if; 1) they had undergone treatment with CPT-11 chemotherapy prior to this study, 2) had active double cancer; 3) had active infection disease (over 38.0C fever); 4) had gastrointestinal paralysis, bowel blockage or history within 1 year before entry; 5) had serious interstitial lung disease and lung fibrosis; 6) had water solubility diarrhea; 7) had diabetes mellitus which could not be controlled; 8) had hypertension which could not control with drug therapy; 9) had proteinuria > 2 plus 10) had serious complication (e.g. heart failure, hepatic failure, kidney failure); 11) had comorbid disease of cerebral vascular disorder or history within 1 year before entry; 12) were operated or performed dissected biopsy within 4 weeks before entry; 13) were bleeding tendency, coagulation disorder, abnormality of coagulation factor (INR>1.5) within 2 weeks before entry; 14) were administered antithrombotic within 10 days before entry; 15) were administered antiplatelet agent for chronic rheumatoid arthritis; 16) were administred flucytosine or atazanavir ; 17) were systemically-administered of steroids ; 18) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant ; 19) had a previous serious medical illness or allergy for drugs ; 20) had brain metastasis or had treated for brain metastasis ; 21) had myelosuppression ; 22) had pleural effusion or abdominal dropsy which need therapy ; 23) had jaundice ; 24) except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.

Related Information

• Primary Sponsor: Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
• Secondary Sponsor: Niigata Colorectal cancer Chemotherapy Study Group
• Source(s) of Monetary Support: None