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

Colorectal Cancer Clinical Trial

Official title: A Randomized Phase II Trial of Induction Regimen With mFOLFOX6 and Ziv-aflibercept for First-line Therapy of Metastatic Colorectal Cancer Followed by Continuation Regimen With 5-FU/LV Alone or With Ziv-aflibercept Until Disease Progression

Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

All patients will receive an induction regimen with mFOLFOX6 (5-FU 400 mg/m2 IV bolus Day 1 + leucovorin 400 mg/m2 IV Day 1 + oxaliplatin 85 mg/m2 IV Day 1 followed by 5-FU 2400 mg/m2 by continuous intravenous infusion (CIV infusion) over 46 hours [Day 1 and 2]) + ziv-aflibercept (4 mg/kg on Day 1) every 14 days for 6 cycles.

Patients attaining stable disease or better after 6 cycles of induction therapy will be randomized to receive a continuation regimen of either 5-FU/LV + ziv-aflibercept IV [4 mg/kg Day 1]) every 14 days, as the investigational arm; or 5-FU/LV alone every 14 days, as the control arm, until disease progression.

Toxicity will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0.

Submission of archived primary tumor tissue and blood samples for FC-8 correlative science studies will be a study requirement for all patients. Submissions will include primary tumor specimens from the diagnostic biopsy sample or another previous surgery and blood samples collected before the start of study therapy, prior to starting each even numbered cycle of therapy, (i.e., Cycles 2, 4, and 6) and at the time of disease progression or end of study therapy.

The total study accrual will be up to 120 patients over a period of 24 months in order to provide 90 patients for randomization to the continuation regimen. Patients will be randomized 2:1 to receive the continuation regimen of 5-FU/LV + ziv-aflibercept (Arm 2, 60 patients) or 5-FU/LV alone (Arm 1, 30 patients).

In both arms, clinical response will be assessed by radiological examination every eight weeks during the continuation regimen course. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT01889680
• Study type: Interventional
• Source: NSABP Foundation Inc
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2014
• Completion date: May 2018