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

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ClinicalTrials.gov Identifier: NCT00541125
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

October 5, 2007
October 8, 2007
May 30, 2016
November 2007
September 2013   (Final data collection date for primary outcome measure)
  • Rate of neutropenia grade 4 or fever [ Time Frame: 2013 ]
  • Toxicities by NCI-CTC v. 2.0 [ Time Frame: 2013 ]
  • Rate of neutropenia grade 4 or fever
  • Toxicities by NCI-CTC v. 2.0
Complete list of historical versions of study NCT00541125 on ClinicalTrials.gov Archive Site
  • Objective response at 6 months by RECIST [ Time Frame: 2013 ]
  • Tolerance (except neutropenia) by NCI-CTC v. 2.0 [ Time Frame: 2013 ]
  • Progression-free survival [ Time Frame: 2013 ]
  • Overall survival [ Time Frame: 2013 ]
  • Time to treatment failure [ Time Frame: 2013 ]
  • Objective response at 6 months by RECIST
  • Tolerance (except neutropenia) by NCI-CTC v. 2.0
  • Progression-free survival
  • Overall survival
  • Time to treatment failure
Not Provided
Not Provided
 
G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer
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 UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Colorectal Cancer
  • Biological: bevacizumab
  • Biological: filgrastim
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
Interventions:
  • Biological: bevacizumab
  • Biological: filgrastim
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
30
December 2013
September 2013   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • 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

Exclusion criteria:

  • Original tumor not removed
  • CNS metastases
  • Secondary localized cerebral tumors

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • 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

Exclusion criteria:

  • Progressive gastroduodenal ulcer, prior hemorrhagic ulcer, or perforation in the past 6 months
  • Enteropathy or chronic diarrhea
  • Chronic inflammatory intestinal disease
  • Intestinal obstruction
  • Active cardiac disease including any of the following:

    • Uncontrolled hypertension
    • Myocardial infarction in the past 12 months
    • Serious angina
    • NYHA class II-IV congestive heart failure
    • Severe arrhythmia (even if treated)
    • Peripheral vascular disease ≥ grade 2
  • Unhealed wound, ulcer, or severe bone fracture
  • Bleeding disorder or coagulopathy
  • Severe uncontrolled infection or medical condition
  • Proteinuria > 500 mg/24 hours
  • Other malignancy within the past 5 years except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
  • Known dihydropyrimidine dehydrogenase deficiency
  • Severe traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • At least 2 weeks since prior radiotherapy

Exclusion criteria:

  • Prior chemotherapy for metastatic disease except adjuvant chemotherapy completed > 6 months ago
  • Prior irinotecan hydrochloride or bevacizumab
  • Major surgery or biopsy within the past 4 weeks
  • Major surgery planned
  • Puncture in the past week
  • Chronic aspirin (> 325 mg/day) or NSAIDs
  • Concurrent antifungal azoles (e.g., ketoconazole, fluconazole, itraconazole)
  • Concurrent phenytoin (as in yellow fever vaccine)
  • Concurrent Hypericum perforatum (St. John's wort)
  • Oral or parenteral coagulant in the past 10 days and during study therapy

    • Warfarin allowed provided INR < 1.5
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00541125
CDR0000564089
FFCD-0604
EU-20757
EUDRACT-2007-001772-37
Yes
Not Provided
Not Provided
Federation Francophone de Cancerologie Digestive
Federation Francophone de Cancerologie Digestive
Not Provided
Study Chair: Thierry Lecomte, MD CHRU de Tours - Hopital Trousseau
Federation Francophone de Cancerologie Digestive
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP