Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer all solid tumors metastatic refractory advanced solid tumors
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 63
Healthy volunteers: no

Brief summary:
The Primary Phase I objectives are to determine the recommended phase II dose for the capecitabine and aflibercept doublet combination; and to describe any dose limiting and non-dose limiting toxicities. The Phase II Primary objective is to determine progression free survival associated with this regimen. The Phase II secondary objectives are to determine response rate associated with this regimen; to determine overall survival associated with this regimen; and to explore any correlation of clinical outcome with baseline and on treatment changes in blood-based angiogenesis biomarkers.

This open-label, non-randomized phase I/II trial is designed to assess the safety, tolerability and RPTD of capecitabine plus aflibercept in adult subjects with metastatic colorectal cancer.

Detailed description:

Arms:
arm 1: A standard 3+3 dose escalation format will be used. Capecitabine will start at 850mg/m2 to be given on days 1-14 and off days 15-21. If tolerated, the dose will then be escalated to 1000mg/m2 for the next cohort, given on the same schedule. The dose of aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks. arm 2: Once the RPTD of the doublet combination has been identified, an additional 50 subjects with metastatic colorectal cancer will be added to a single, Phase 2 arm

Interventions: intervention 1: Capecitabine and aflibercept
Intervention descriptions: intervention 1: Capecitabine given on days 1-14 and off days 15-21. Dose: Phase 1 cohort 1 850mg/m2 Phase 1 cohort 2 1000mg/m2, Phase 2 RPTD.

Aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks.

Both agents will be administered on a 21-day cycle.

Protocol document: