Phase II trial of bi-weekly cetuximab plus mFOLFOX6 or cetuximab plus mFOLFIRI for unresectable advanced or recurrent KRAS wild type colorectal cancer (T-CORE1201)

Phase 2

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000008298
• Lead Sponsor: Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-29
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

Exclusion Criteria

The exclusion criteria were as follows; 1) Patients who treated transfusion, such as blood products and G-CSF treatment within 7 days before registration. 2) History of severe drug hypersensitivity or allergy. 3) In case of receiving bi-weekly cetuximab plus mFOLFOX, history of severe drug hypersensitivity or allergy with L-OHP. 4) Obvious infection and inflammation (fever with 38.0 degree or higher). 5) Poorly controlled hypercalcemia. 6) Poorly controlled hypertension. 7) Poorly controlled diabetes. 8) Obvious abnormality in ECG or heart disease becomes a clinical problem. 9) Severe pulmonary disease such as interstitial pneumonia, pulmonary fibrosis, severe emphysema. 10) Patient with a mental disorder becomes a clinical problem or a history of a CNS disorder. 11) Active GI tract bleeding. 12) Patient who need drainage of peritoneal, pleural or pericardial effusion. 13) Patient who have wide range bone metastases. 14) Patient who has or clinically suspicious for brain metastasis. 15) Chronic diarrhea may disturb the daily life(watery diarrhea). 16) Gastrointestinal paresthesia and bowel obstruction. 17) Active double cancer. 18) Patients who are treated with atazanavir sulfate. 19) Grade 3 or more hypersensitivity with monoclonal antibody. 20) Patients who were treated with EGFR or EGFR pathway targeted therapy. 21) Patients who are addicted to alcohol or drugs. 22) HBs antigen positive or active hepatitis B. 23) Peripheral sensory neuropathy interfering with daily life. 24) Women who are pregnant, may be pregnant, wish to become pregnant or are lactating. Men who wish their partner to become pregnant. 25) Attending physician determines that the case was inappropriate as the subject of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified