A SINGLE-ARM, MULTICENTER, PHASE II STUDY OF PANITUMUMAB IN COMBINATION WITH CAPECITABINE / OXALIPLATIN IN FIRST-LINE, WILD-TYPE K-RAS METASTATIC COLORECTAL CANCER PATIENTS.
This is a single-arm trial in which previously untreated, wild-type k-ras metastatic
colorectal cancer patients will receive therapy with the combination of panitumumab with
capecitabine and oxaliplatin. During the treatment period of 6 cycles, subjects with
evidence of complete response, partial response or stable disease will continue to receive
the combination of chemotherapy with panitumumab until disease progression, unacceptable
toxicity or withdrawal of consent. Those patients with disease stabilization who are not
appropriate for chemotherapy may continue with panitumumab alone. Patients with disease
progression will be discontinued from chemotherapy and panitumumab and will be followed
every 3 months after the last drug administration until death. Tumor response will be
assessed according to the RECIST criteria (investigator's read of scans), every 6 weeks
through week 18 and every 3 months thereafter, until disease progression. Disease
progression will also be evaluated radiographically at the time of clinical suspicion of
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response will be evaluated using the RECIST criteria. Response rates will be presented as counts and proportions along with 95% exact confidence intervals. An Objective Response is defined as either a Complete Response or a Partial Response. Analysis will be performed in the intent-to-treat population, i.e. all eligible patients enrolled in the study.
Tumor response will be assessed every 6 weeks through week 18 and every 3 months thereafter, until disease progression.
Dimitrios Pectasides, Professor
General Hospital of Athens"Hippokratio", 2nd Dept of Internal Medicine
Greece: Ethics Committee