An open-label, randomized, multicenter, phase II trial designed to estimate the activity of CAPTEM combination versus FOLFIRI as second line treatment in patients who have progressed on or after first-line oxaliplatin - containing chemotherapy for advanced, MGMT methylated, RAS mutated colorectal cancer - CAPTEM vs FOLFIRI

Overview

No summary available.

Registry

who.int

Start Date

July 7, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Signed Informed Consent Form
•Histologically or cytologically confirmed adenocarcinoma of the colon and/or rectum, with MGMT promoter methylation and RAS mutation.
•Progressive disease on or after a first\-line oxaliplatin\-containing chemotherapy regimen for mCRC with or without bevacizumab or other anti\-angiogenic drugs. Patients with documented disease relapsed within 6 months from the completion of adjuvant oxaliplatin\-based chemotherapy are considered eligible.
•Patients must have received oxaliplatin\-containing chemotherapy for \= 3 months. No more than one prior chemotherapy regimen for metastatic disease is allowed.
•Disease that is measurable per RECIST v1\.1
•Age \= 18 years and \= 75 years
•Life expectancy \= 12 weeks
•ECOG Performance Status of 0 or 1
•Adequate hematologic and end\-organ function, defined by the following laboratory results obtained within 14 days prior to first administration of study treatment: ANC \= 1500/µL Platelet count \= 100,000/µL Hemoglobin \= 9\.0 g/dL Albumin \= 2\.5 g/dL
•Total bilirubin \= 1\.5 × the upper limit of normal (ULN)

•Prior treatment with irinotecan and temozolomide
•Major surgical procedure within 4 weeks and radiotherapy within 2 weeks prior to Day 1 Cycle 1
•Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
•Known clinically significant dihydropyrimidine dehydrogenase deficiency
•Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound\-healing disorders; ulcers or bone fractures), active infection requiring IV antibiotics
•History of heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
•History of myocardial infarction within 6 months prior to Cycle 1, Day 1, or history of unstable angina
•Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; or current alcohol abuse
•History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
•Patients receiving oral coumarin\-derived anticoagulants