Phase II clinical trial of the third-line Cetuximab and irinotecan or Cetuximab therapy for patients with KRAS wild type unresectable/recurrent colorectal cancer
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000001963
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
Not provided
1)active other malignancies within 5 years 2) history of the 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 and so on) 5) Patients who have abnormal findings on ECG and need any treatment (within 4 weeks before the registration.) 6) Moderate/severe pleural effusion or ascites 7) Symptomatic brain metastasis 8)Patient need transfusion because GI bleeding 9) Uncontrolled watery diarrhea. Watery colostomy output without trouble with patient's daily living is allowed. 10) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse. 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events of grade 3/4
- Secondary Outcome Measures
Name Time Method Response Rate, Progression free survival, Overall survival,Time to progression, The incidence of grade 3/4 Skin toxicity,Time to progression of irinotecan combined regimen(A group)