G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Biological: bevacizumab; Biological: filgrastim; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

• Registration Number: NCT00541125
• Lead Sponsor: Federation Francophone de Cancerologie Digestive

Brief Summary

RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer.

PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to obtain neutropenia lower than grade 4 or a 30% decrease in fever in patients with metastatic colorectal cancer receiving first-line FOLFIRI and bevacizumab and who are homozygous for allele UGT1A1\*28 (genotype 7/7), a promoter of the gene coding for enzyme UGT1A1.

Secondary

* Evaluate the objective response rate at 6 months of treatment with FOLFIRI and bevacizumab according to RECIST criteria.

* Evaluate the toxicity (excluding neutropenia) of FOLFIRI and bevacizumab according to NCI-CTC v. 2.0.

* Determine progression-free and overall survival.

* Determine the time to treatment failure.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 5-11. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 2-3 months for up to 5 years.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Study Start: 2007-11
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2016-05
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire	leucovorin calcium	FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire	filgrastim	FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire	bevacizumab	FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire	irinotecan hydrochloride	FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire	fluorouracil	FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

Primary Outcome Measures

Name	Time	Method
Rate of neutropenia grade 4 or fever	2013
Toxicities by NCI-CTC v. 2.0	2013

Secondary Outcome Measures

Name	Time	Method
Objective response at 6 months by RECIST	2013
Tolerance (except neutropenia) by NCI-CTC v. 2.0	2013
Time to treatment failure	2013
Overall survival	2013
Progression-free survival	2013