Adjuvant Aflibercept for Metastatic Colorectal Cancer

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT01669720
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Aflibercept — DRUG
    Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years

Study Details

The main purpose of this study is to evaluate if aflibercept can reduce the chance that metastatic (spread of) colorectal cancer can grow back after finishing standard treatment. The study will also look at the side effects of aflibercept and the effect on quality of life.

Key Dates

Start date
Dec 31, 2012
Status verified
Feb 2020
Primary completion
Dec 31, 2015
Completion
Jan 31, 2016

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept
    Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
  • No Intervention: Observation
    Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.

Primary Outcome Measure

Number of Patients Who Progressed [ Time Frame: Every 3 months until disease progression (for up to 2 years). ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rhode Island Hospital (East Greenwich and Newport)ProvidenceRhode Island02903-
The Miriam HospitalProvidenceRhode Island02903-

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