Multicenter phase II trial of panitumumab plus irinotecan and S-1 (PIRIS regimen) in patients treated by oxaliplatin-based chemotherapy with K-RAS wild-type advanced colorectal cancer.
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004574
- Lead Sponsor
- Showa University Nothern Yokohama Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
Not provided
1)A history of CPT-11 or cetuximab (C225) use. 2)A history of serious drug hypersensitivity or serious drug allergy. 3)Clinically important infection or suspected infection in febrile patients. 4)Diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma. 5)Active double cancer. 6)Paralytic or occlusive ileus. 7)Uncontrolled body cavity fluid. 8)Symptomatic brain metastasis. 9)Clinically significant heart disease. 10)Severe pulmonary disease. 11)Gastrointestinal ulceration or bleeding. 12)Central nervous system disorders. 13)Uncontrolled diabetes. 14)Women who are pregnant, lactating, or wish to become pregnant or men who expect babies. 15)Judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc. 16)Under treatment with atazanavir, flucytosine, phenytoin, warfarin potassium 17)Judged to be ineligible by principal investigator for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response ratte : RR
- Secondary Outcome Measures
Name Time Method 1)Progression free survival :PFS 2)Time to treatment failure :TTF 3)Overall survival :OS 4)Skin toxitiy 5)Adverse Event :AE