Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000019893
- Lead Sponsor
- The Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
Receive blood infusion, G-CSF within 7days before primary registration. UGT1A1*28 homo, *6 homo,*28*6 Severe heart disease. Severe liver disease. Severe lung disease. Active gastrointestinal bleeding. Severe mental disease. Severe diabetes. Ileus. Active infectious disease. Other active cancer. Cerebral metastasis. Icterus . Severe diarrhea. Severe allergic reaction for drugs (irinotecan anti-EGFR antibody). Massive ascites, plerural effusion. Under treatment with atazanavir. Past history of treatment with EGFR antibody. Alcoholic or drug Intoxication. Hbs antibody positive. HCV antibody positive. HIV antibody positive. A pregnant woman, a woman in breast-feeding, a man who expects his baby. An inappropriate case judged by docter in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Progression free survival Overall survival Pharmacokinetic parameter Safety profile