Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00541125
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2007-10-05
Brief Title:
G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
Phase II Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A128 Polymorphism the Promoter of the Gene Encoding for the Enzyme UGT1A1
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 UGT1A128 genotype 77 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 20
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
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 UGT1A128 genotype 77 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 20
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FFCD-0604 | None | None | None |
| EU-20757 | None | None | None |
| EUDRACT-2007-001772-37 | None | None | None |