Phase II study of a combination of CPT-11 and S-1 and Panitumumab in patients with KRAS wild-type metastatic colon cancer.
- Conditions
- KRAS wild-type metastatic colon cancer.
- Registration Number
- JPRN-UMIN000005368
- Lead Sponsor
- iigata Colorectal cancer Chemotherapy Study Group (NCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival
- Secondary Outcome Measures
Name Time Method Response Rate Overall survial Time to Treatment Failure Safety