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

NCT00541125 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000564089FFCD-0604EU-20757EUDRACT-2007-001772-37
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (2)

• Rate of neutropenia grade 4 or fever

  2013

• Toxicities by NCI-CTC v. 2.0

  2013

Secondary Outcomes (5)

• Objective response at 6 months by RECIST

  2013

• Tolerance (except neutropenia) by NCI-CTC v. 2.0

  2013

• Progression-free survival

  2013

• Overall survival

  2013

• Time to treatment failure

  2013

Study Arms (1)

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

OTHER

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

Biological: bevacizumab; Biological: filgrastim; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium

Interventions

bevacizumab BIOLOGICAL

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

filgrastim BIOLOGICAL

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

fluorouracil DRUG

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

irinotecan hydrochloride DRUG

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

leucovorin calcium DRUG

FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the colon or rectum
• Metastatic disease
• Not surgically curable
• Homozygous for allele UGT1A1\*28, the promoter of the gene coding for UGT1A1 (genotype 7/7)
• Measurable and/or evaluable disease

You may not qualify if:

• Original tumor not removed
• CNS metastases
• Secondary localized cerebral tumors
• PATIENT CHARACTERISTICS:
• WHO performance status 0-2
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Creatinine \> 1.5 mg/dL
• Total bilirubin ≤ 1.5 times normal
• Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients of must use effective contraception
• Progressive gastroduodenal ulcer, prior hemorrhagic ulcer, or perforation in the past 6 months

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Filgrastim; Fluorouracil; Irinotecan; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Thierry Lecomte, MD

  CHRU de Tours - Hopital Trousseau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 30, 2020

Record last verified: 2016-05