Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients
Status:
Completed
Trial end date:
2019-07-30
Target enrollment:
Participant gender:
Summary
Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of
CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC
patients who have progressed on or after first-line oxaliplatin containing chemotherapy for
metastatic disease. MGMT will be assessed centrally at Pathology Department of Fondazione
IRCCS Istituto Nazionale dei Tumori prior to enrollment. A minimum of ten 3-micron unstained
sections on charged slides of tumor will be required and methylation status will be provided
within a maximum of seven days to the Study Centers. Presence of RAS mutation will be
assessed at each local participating center. Eligible patients will be randomized in a 1:1
ratio to one of two treatment arms:
- Arm A (experimental arm): CAPTEM
- Arm B (control arm): FOLFIRI Study treatment will be given in cycles repeated every 28
days for Arm A and every 14 days for Arm B. Patients in Arm A will receive capecitabine
at the oral dose of 1500 mg/mq/die bid from day 1 to day 14 every 28 days plus
temozolomide 150 mg/mq/die bid starting on day 9 to 14 every 28 days. Patients in Arm B
will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of
Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only;
5-FU 7 (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2,
respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting
dose of 100 mg/m2) for two consecutive days. Treatment will continue for up to 6 cycles
in Arm A and up to 12 cycles in Arm B or up to disease progression, unacceptable
toxicity or informed consent withdrawal. Randomization will be stratified across the
treatment arms by the following predefined stratification variables: disease progression
within 9 months from the start of first-line oxaliplatin-containing chemotherapy (< vs.
≥9 months); prior bevacizumab in combination with oxaliplatin-based chemotherapy (yes
vs. no). Efficacy assessments will be performed every 2 cycles in Arm A and every 4
cycles in Arm B until progression. The study is expected to enrol approximately 82
patients who meet the eligibility criteria.
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano