Phase I/II Study of Capecitabine Plus Aflibercept to Treat Metastatic Colorectal Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
John Strickler, M.D.
Study ID
NCT01661972
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capecitabine and aflibercept — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2012
Status verified
Oct 2018
Primary completion
Jun 12, 2016
Completion
Jun 12, 2016

Study Design

Enrollment
63 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Capecitabine and Aflibercept
    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.
  • Experimental: Phase 2: Capecitabine and Aflibercept
    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

Primary Outcome Measure

Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination [ Time Frame: RPTD for the study will be determined at the completion of Phase I; up to 1 year. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Duke Cancer Center, Duke University Medical CenterDurhamNorth Carolina27710-
Virginia Oncology AssociatesNorfolkVirginia23502-

Find similar trials in Durham, NC

By research site
Duke Cancer Center, Duke University Medical Center· Durham, NCVirginia Oncology Associates· Norfolk, VA

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