Phase II clinical trial of third-line Panitumumab and irinotecan or Panitumumab therapy for patients with KRAS wild-type unresectable/recurrent colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000004647
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1) other active malignancies within 5 years 2) history of severe drug hypersensitivity 3) clinically significant infectious disease (body temperature less than 38.0 degrees) 4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure, etc.) 5) patients who have abnormal findings on ECG and need any treatment (within 4 weeks before registration) 6) moderate/severe pleural effusion or ascites 7) symptomatic brain metastasis 8) patients who need transfusion because of GI bleeding 9) uncontrolled watery diarrhea (watery colostomy output without trouble during patient's daily living is allowed) 10) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who do not intend to have protected intercourse 11) any other cases who are regarded as unsuitable for enrollment in the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate of Panitumumab + irinotecan regimen
- Secondary Outcome Measures
Name Time Method Progression-free survival, Overall survival, Time to progression, Time to progression of irinotecan combined regimen, Feasibility of Short-term Infusion of Panitumumab, Incidence of grade 2/3/4 skin toxicity during the skin treatment period