Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00628810
Last Updated: 2020-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2007-01-31
2008-12-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.
Detailed Description
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Primary
* Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy.
* Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.
Secondary
* Evaluate progression-free survival and overall survival.
* Determine the time to treatment failure.
* Evaluate the quality of life (EuroQOL EQ5D questionnaire).
* Explore the prognostic factors associated with the tolerability and efficacy of this treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1\*1/ UCT1A1\*1 vs UCT1A1\*1/ UCT1A1\*28).
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. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy.
After completion of study therapy, patients are followed every 2-3 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FOLFIRI fort plus bevacizumab
Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study.
bevacizumab
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Interventions
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bevacizumab
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
* Life expectancy ≥ 3 months
* Absolute neutrophil count ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Hemoglobin ≥ 9.0 g/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
* Enteropathy or chronic diarrhea
* Proteinuria \> 500 mg/24 hours
* Active cardiac disease
* Uncontrolled hypertension
* Myocardial infarction in the past 12 months
* Angina
* NYHA grade II-IV congestive heart disease
* Severe arrhythmia even with treatment
* Peripheral vascular disease ≥ grade II
* Nonhealing wound, ulcer, or severe bone fracture
* Hemorrhagic diatheses or coagulopathy
* Severe or uncontrolled infection
* Severe or uncontrolled medical condition
* Other malignant disease in the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the uterine cervix
* Severe traumatic injury within the past 4 weeks
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for metastatic disease
* One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the original tumor allowed
* At least 6 months since prior chemotherapy
* No prior irinotecan hydrochloride or bevacizumab
* No oral or parenteral anticoagulant therapy within the past 10 days
* Warfarin allowed provided INR \< 1.5
* No major surgery or biopsy within the past 4 weeks
* No puncture in the past 7 days
* No planned major surgery
* No concurrent daily or chronic aspirin (\> 325 mg/day), anti-inflammatories, or steroids
* No other concurrent anticancer therapy
18 Years
74 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Martina Schneider
Role: STUDY_CHAIR
Federation Francophone de Cancerologie Digestive
Locations
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Centre Hospitalier d'Abbeville
Abbeville, , France
Centre Hospitalier Universitaire d'Amiens
Amiens, , France
Hopital Duffaut
Avignon, , France
C.H.G. Beauvais
Beauvais, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Pierre Oudot
Bourgoin, , France
Centre Hospitalier General
Brivé, , France
CHU de Caen
Caen, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier de Chalons-en-Champagne
Châlons-en-Champagne, , France
Hopitaux Civils de Colmar
Colmar, , France
Hopital Du Bocage
Dijon, , France
Federation Francophone de Cancerologie Digestive
Dijon, , France
Clinique Saint Vincent
Épernay, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Hopital Andre Mignot
Le Chesnay, , France
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicêtre, , France
CHU de la Timone
Marseille, , France
CHU Nord
Marseille, , France
Hopital de l'Archet CHU de Nice
Nice, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
CHU - Robert Debre
Reims, , France
Hopital Charles Nicolle
Rouen, , France
Clinique Mathilde
Rouen, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
CHRU de Tours - Hopital Trousseau
Tours, , France
Centre Hospitalier General Lucien Hussel
Vienne, , France
Clinique du Tonkin
Villeurbanne, , France
Countries
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References
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Manfredi S, Bouche O, Rougier P, Dahan L, Loriot MA, Aparicio T, Etienne PL, Lafargue JP, Lecaille C, Legoux JL, Le Malicot K, Maillard E, Lecomte T, Khemissa F, Breysacher G, Michel P, Mitry E, Bedenne L. High-Dose FOLFIRI plus Bevacizumab in the Treatment of Metastatic Colorectal Cancer Patients with Two Different UGT1A1 Genotypes: FFCD 0504 Study. Mol Cancer Ther. 2015 Dec;14(12):2782-8. doi: 10.1158/1535-7163.MCT-15-0293. Epub 2015 Oct 22.
Other Identifiers
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FFCD-0504
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2006-003157-25
Identifier Type: -
Identifier Source: secondary_id
EU-20755
Identifier Type: -
Identifier Source: secondary_id
CDR0000564065
Identifier Type: -
Identifier Source: org_study_id