Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer
- Conditions
- RAS wild-type unresectable colorectal cancer
- Registration Number
- JPRN-UMIN000015620
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
1) Symptomatic brain metastasis. 2) Diarrhea greater than Grade 2. 3) Paralytic or mechanical bowel obstruction. 4) Confirmed orsuspected active infection. 5) Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema). 6) Serious complications (uncontrolled diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure). 7) Coronary heart disease or myocardial infarction within 12 months prior to the registration. 8) Women who are pregnant or breastfeeding. Patients who are unwilling to avoid pregnancy. 9) Carcinomatous meningitis, uncontrolled convulsive attack, mental disorders, or clinically important CNS diseases. 10) Peripheral neuropathy greater than Grade 2. 11) UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28. 12) Administration of phenytoin, warfarin, or atazanavir sulfate. 13) History of severe drug-induced hypersensitivity syndrome. 14) History of hypersensitivity greater than Grade 2 after FOLFOX therapy. 15) Prior anti-EGFR antibodies. 16) Unrecoverd from surgey within 4 weeks prior to the registration. 17) Radiotherapy within 4 weeks prior to the registration. 18) massive pleural, abdominal, or cardiac effusion. 19) HBs-Ag(+), HCV-Ab(+), or HIV-Ab(+). 20) Active multiple malignancy. 21) Any other cases who are regarded as inadequate for study enrollment by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recommended dose
- Secondary Outcome Measures
Name Time Method Response rate Safety