Randomized phase II trial of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab with exploratory analysis to predict treatment efficacy and prognosis

Phase 2

• Conditions: Colorectal cancer

• Registration Number: JPRN-UMIN000005216
• Lead Sponsor: West Japan Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

1) previous history of chemotherapy including irinotecan, cetuximab, or panitumumab 2) symptomatic brain metastasis or brain metastasis with under medication 3) intestinal obstruction 4) uncontrollable ascites or pleural effusion 5) uncontrollable diarrhea 6) having other active malignancies 7) having active infections 8) pulmonary fibrosis or interstitial pneumonia 9) serious comorbidities, such as uncontrollable diabetes mellitus, severe heart disease (NYHA>III), renal failure, and liver failure 10) History of arterial thromboembolic events such as unstable angia, myocardial infarction, brain hemorrhage, and brain infarction within 6 months. 11) having wound healing problem (excluding central venous port) 12) History of major surgery within 28 days or 14 days after colostomy. 13) Meningitis carcinomatosis or uncontrollable seizures, serious mental problem or neurologic disorders 14) continuous steroid administration 15) serious drug allergy 16) HIV infection 17) Pregnant or lactating female 18) Other serious medical conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression freer survival, response rate, safety, translational research