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NCT00561470

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen

Last Updated: 2012-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-06-30

Brief Summary

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The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.

The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

Detailed Description

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Participants were

* randomized at baseline (treatment was initiated with 3 days of randomization)
* administered treatment in cycles of 14-days till a study withdrawal criterion was met
* followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study.

The criteria for discontinuation of study treatment for a participant are:

* participant (or legal representative) chose to withdraw from treatment
* the investigator thought that continuation of the study would be detrimental to the participants well-being due to

* disease progression
* unacceptable AEs
* intercurrent illnesses
* non-compliance to the study protocol
* participant was lost to follow-up
* participant was unblinded for the investigational treatment

Conditions

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Colorectal Neoplasms Neoplasm Metastasis

Keywords

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colorectal cancer metastatic anti-angiogenic irinotecan 5-FU FOLFIRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo/FOLFIRI

Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Intervention Type DRUG

The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1

The FOLFIRI regimen included:

* 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
* 5-FU 2400 mg/m² continuous IV infusion over 46-hours

Aflibercept/FOLFIRI

Participants with Metastatic Colorectal Cancer administered Aflibercept followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met

Group Type EXPERIMENTAL

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

Intervention Type DRUG

4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Intervention Type DRUG

The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1

The FOLFIRI regimen included:

* 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
* 5-FU 2400 mg/m² continuous IV infusion over 46-hours

Interventions

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Placebo

4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks

Intervention Type DRUG

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

Intervention Type DRUG

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Intervention Type DRUG

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Metastatic disease that is not amenable to potentially curative treatment
* One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
* Prior treatment with bevacizumab is permitted.

Exclusion Criteria

* Prior therapy with irinotecan
* Eastern Cooperative Oncology Group performance status \>2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Investigational Site Number 840119

Birmingham, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840074

Muscle Shoals, Alabama, United States

Site Status

Sanofi-Aventis Investigational Site Number 840093

Hot Springs, Arizona, United States

Site Status

Sanofi-Aventis Investigational Site Number 840080

Anaheim, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840076

Fountain Valley, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840120

Fountain Valley, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840073

Greenbrae, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840101

Hayward, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840046

La Jolla, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840116

Loma Linda, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840048

Long Beach, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840201

Oakland, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840901

Roseville, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840042

Sacramento, California, United States

Site Status

Sanofi-Aventis Investigational Site Number 840301

Sacramento, California, United States

Site Status