OPTIMOX-aflibercept as First-line Therapy in Patients With Unresectable Metastatic Colorectal Cancer

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT01802684
Phase
PHASE2
Status
Completed

Conditions

  • Unresectable Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • aflibercept — BIOLOGICAL
    Aflibercept (VEGF Trap) Recombinant human protein, at 25 mg/ml Dose : 4 mg/Kg -Day 1, q2w Route of administration: Intravenous (60 min infusion)

Study Details

Evaluation of feasibility of adding aflibercept to an oxaliplatin-based regimen rather than a continuous administration of chemotherapy until progression, in order to decrease the risk of severe toxicities.

Key Dates

Start date
May 31, 2013
Status verified
Feb 2017
Primary completion
Nov 30, 2014
Completion
Jun 30, 2016

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OPTIMOX-aflibercept
    Induction therapy (sequence #1) * Regimen : aflibercept + modified FOLFOX7 * Duration : 6 cycles (3 months) Maintenance after induction (sequence #2) First phase (sequence #2A) * Regimen : aflibercept + fluoropyrimidine (simplifed LV5FU2 or capecitabine) * Duration : 6 cycles (3 months) Second phase (sequence #2B) * Regimen : aflibercept +/- fluoropyrimidine (simplifed LV5FU2 or capecitabine) according to eligibility criteria for chemotherapy-free interval) * Duration : until PD or limiting toxicity Reintroduction (sequence #3) * Regimen : aflibercept + modified FOLFOX7 * Duration : 6 cycles (3 months) Maintenance after reintroduction (sequence #4) * Regimen : aflibercept + fluoropyrimidine * Duration : until PD or limiting toxicity

Primary Outcome Measure

Progression free survival at 6 months [ Time Frame: time interval from inclusion to the date of first documented disease progression or death from any cause, whichever occurs first. Assessed at 6 months. ]

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