Phase II study of panitumumab with FOLFOX or FOLFIRI as 1st line treatment in patients with metastatic colorectal cancer in Japa
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000004991
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 165
Not provided
1) Prior severe drug allergy 2) Synchronous and/or metachronous multiple cancers 3) Severe bowel stenosis by the primary tumor (ex. after colostomy) 4) Prior adjuvant chemotherapy with oxaliplatin containing regimen 5) Surgical procedure within 28 days prior to enrollment (ex. venous reservoirs implant, colostomy) 6) Severe comorbidity: - severe pulmonary dysfunction - Uncontrolled DM - Uncontrolled HT - severe cardiovascular disease - Cirrhosis and liver failure - Renal failure 7) Sensory neuropathy 8) Severe diarrhea 9) Active infection 10) Symptomatic pleural effusion or ascites 11) Contraindications to 5-FU, l-LV, panitumumab, L-OHP or CPT-11 12) Concerning pregnancy 13) The investigator considers not suitable for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method - Safety - Progression free survival (PFS) - Overall survival (OS) - Time to progression (TTP) - Time to treatment failure (TTF) - Disease control rate - R0-resection rate - Histological investigation of the post-treatment liver tissues - Correlation between clinico-pathological factors and efficacy