phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004500
- Lead Sponsor
- Jichi medical university
- Brief Summary
https://www.spandidos-publications.com/ol/11/6/4049/abstract
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 45
Not provided
1) symptomatic brain metastasis 2) waterly diarrhea 3) Paralytic or mechanical bowel obstruction 4) severe infectious disease 5) severe plumonary disease (interstitial lung disease or plumonary fibrosis) 6) severe complications (uncontrolable diabetes, heart failure NYHA>=III, renal failure, liver failure) 7) Pregnant or lactating women or women of childbearing potential 8) carcinomatosis meningitis 9) peripheral neuropathy Grade>=3 10)Need to treatment with flucytosine, atazanavir sulfate 11) history of Grade>=3 hypersensitivity due to monoclonal antibody therapy 12) history of Grade>=3 hypersensitivity due to irinotecan 13) history of treatment of anti EGFR pathway 14) patients judged inappropriate for this study by physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method disease control rate, duration of response, progression free survival, overall survival, incidence of adverse events.