Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type (OGSG 0901)
- Conditions
- advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
- Registration Number
- JPRN-UMIN000002695
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Not provided
1) with treatments including CPT-11 and/or Cetuximab 2) with active double cancers 3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 4) Infectious disease 5) Diarrhea (watery stools) 6) with obstruction or disorder on digestive tract due to peritoneal metastasis 7) with ascites and/or pleural fluid 8) History of serious drug hypersensitivity 9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate. 10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion. 11) With liver cirrhosis or jaundice. 12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment. 13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment. 14) With diabetes that is difficult to control. 15) With central nervous system metastasis 16) women pregnant, breast-feeding, or who wish pregnancy 17) Any other patient whom the physician in charge of the study judges to be unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method