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Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer

NCT01889680 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-12-02

No results posted yet for this study

Summary

FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6 and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer. The primary aim of the study is to determine the value of adding ziv-aflibercept to the continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients with metastatic colorectal cancer who have achieved at least stable disease after induction therapy. The secondary aim is to determine the overall objective response rate (complete, partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Conditions

Interventions

DRUG

5-FU

400 mg/m2 IV bolus day 1 followed by 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days until disease progression

DRUG

LV

400 mg/m2 IV day 1 every 14 days until disease progression

DRUG

ziv-aflibercept

4 mg/kg IV day 1 every 14 days for 6 cycles (induction regimen); 4 mg/kg IV day 1 every 14 days until disease progression (continuation regimen)

DRUG

mFOLFOX6

5-FU 400 mg/m2 IV bolus plus leucovorin 400 mg/m2 IV plus oxaliplatin 85 mg/m2 IV on day 1 followed by 5-FU 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • NSABP Foundation Inc

    lead NETWORK

Principal Investigators

  • Norman Wolmark, MD · NSABP Foundation Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-05-31
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889680 on ClinicalTrials.gov