Phase I study of 5-FU + Oxaliplatin + Irinotecan + Levofolinate + Panitumumab as the first-line therapy in patients with KRAS or RAS wild-type metastatic colorectal cancer
- Conditions
- KRAS or RAS wild-type metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000015475
- Lead Sponsor
- onprofit Organization Japan Clinical Cancer Research Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
(1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval. (2) Administration of blood products/ G-CSF, and blood transfusion within 14 days. (3) Brain metastases. (4) Active infection. (5) Serious complication (Interstitial pneumonia, Chronic obstructive pulmonary, Idiopathic pulmonary fibrosis, Renal failure, Hepatic failure, Uncontrolled Deabetes, Uncontrolled hypertention, Angina requiring treatment, Cardiac failure, Jaundice). (6) Ileus or bowel obstruction. (7) Large quantity of pleural, abdominal or cardiac effusion. (8) diarrhea. (9) peripheral neuropathy greater than Grade 2. (10) Active viral hepatitis. (11) Administration of atazanavir sulfate. (12) History of severe allergy. (13) History of organ recipient. (14) History of myocardial infarction, unstable angina within 3 months prior to the registration. (15) Prior Panitumumab/Irinotecan/Oxaliplatin treatment. (Adjuvant therapy by Oxaliplatin is excluded) (16) severe mental disorders. (17) Systemic steroid user. (18) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (19) 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 Completion rate of the protocol treatment (Until 12 courses) Time to Treatment Failure Overall Survival Progression Free Survival Safety Response Rate