Phase I study of XELOXIRI(CPT-11,L-OHP, capecitabine) with Bevacizumab in patients with unresectable advanced/metastatic colorectal cancer
Phase 1
Recruiting
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000005440
- Lead Sponsor
- Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1)Prior severe drug allergy. 2) Synchronous and/or metachronous multiple cancers. 3) Prior chemotherapy with CPT-11,L-OHP, capecitabeine or Bevacizumab containing regimen. 4)Surgical procedure within 28 days prior to enrollment. 5) Severe comorbidity - Severe pulmonary dysfunction - Uncontrolled DM - Uncontrolled HT - Severe cardiovascular disease - Cirrhosis and liver failure - Renal failure 6) Sensory neuropathy 7) Severe diarrhea 8) Active infection 9) Symptomatic pleural effusion or ascites 10)Contraindications to CPT-11, L-OHP, capecitabeine or Bevacizumab 11) Concerning pregnancy 12) The investigator considers not suitable for the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Response rate