A Multicenter single arm Phase II clinical trial of the second-line treatment with FOLFIRI plus panitumumab after failure of the first-line treatment with FOLFOX plus panitumumab for advanced and/or recurrent RAS wild-type colorectal cancer with special reference to the changes in biomarker expression examined by a liquid biopsy and its effect on the refractory tumor

Not Applicable

Recruiting

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000026817
• Lead Sponsor: PO Epidemiological and Clinical Research Information Network(ECRIN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

1) History of other malignancy with a disease-free interval <5 years 2) With massive pleural effusion or ascites requiring intervention 3) Radiological evidence of brain tumor or brain metastases 4) Active infection including hepatitis 5) Any of the following complication: i) Gastrointestinal bleeding or gastrointestinal obstruction ii) Symptomatic heart disease iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea 6) Any of the following medical history: i) Myocardial infarction ii) Serious hypersensitivity iii) History of adverse reaction to fluoropyrimidines iv) Previous treatment with irinotecan hydrochloride v) Current treatment with atazanavir sulfate vi) Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment vii) Pregnant and lactating females viii) Requires continuous treatment with systemic steroids ix) Psychiatric disability x) unsuitable for participation in the study xi) History of pulmonary hemorrhage/hemoptysis more than Grade 2 xii) History of laparotomy, thoracotomy, or intestinal resection within 28 days xiii) Unhealed wound xiv) Current or recent (within 1 year) thromboembolism or cerebrovascular disease xv) Currently receiving or requires anticoagulation therapy (more than 325 mg/day of aspirin) xvi) Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR more than 1.5 within 14 days before enrollment)xvii) Uncontrolled hypertension xviii) Urine dipstick for proteinuria more than +2

Study & Design

• Study Type: Interventional
• Study Design: Not specified