Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study
4 other identifiers
interventional
86
1 country
32
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started Jan 2007
Shorter than P25 for phase_2 colorectal-cancer
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 4, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 9, 2020
November 1, 2020
1 year
March 4, 2008
November 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective response at 6 months by RECIST
6 months
Tolerability evaluated by NCI CTC v. 2.0 criteria
From Inclusion
Secondary Outcomes (3)
Progression-free and overall survival
From Inclusion
Time to treatment failure
From Inclusion
Quality of life using the EuroQOL EQ5D questionnaire
From Inclusion
Study Arms (1)
FOLFIRI fort plus bevacizumab
EXPERIMENTALBevacizumab 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.
Interventions
Eligibility Criteria
You may qualify if:
- WHO performance status 0-2
- 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
You may not qualify if:
- Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6 months
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Centre Hospitalier d'Abbeville
Abbeville, 80101, France
Centre Hospitalier Universitaire d'Amiens
Amiens, 80054, France
Hopital Duffaut
Avignon, 84902, France
C.H.G. Beauvais
Beauvais, 60021, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, 25030, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
Hopital Ambroise Pare
Boulogne-Billancourt, F-92104, France
Centre Hospitalier Pierre Oudot
Bourgoin, 38300, France
Centre Hospitalier General
Brivé, 19101, France
CHU de Caen
Caen, 14033, France
Centre Regional Francois Baclesse
Caen, 14076, France
Centre Hospitalier de Chalons-en-Champagne
Châlons-en-Champagne, 51000, France
Hopitaux Civils de Colmar
Colmar, 68024, France
Hopital Du Bocage
Dijon, 21034, France
Federation Francophone de Cancerologie Digestive
Dijon, 21079, France
Clinique Saint Vincent
Épernay, 51200, France
Centre Hospitalier Departemental
La Roche-sur-Yon, F-85025, France
Hopital Andre Mignot
Le Chesnay, 78157, France
Centre Hospitalier Universitaire de Bicetre
Le Kremlin-Bicêtre, 94275, France
CHU de la Timone
Marseille, 13385, France
CHU Nord
Marseille, 13915, France
Hopital de l'Archet CHU de Nice
Nice, F-06202, France
CHR D'Orleans - Hopital de la Source
Orléans, 45100, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Hopital Bichat - Claude Bernard
Paris, 75018, France
CHU - Robert Debre
Reims, 51092, France
Hopital Charles Nicolle
Rouen, 76031, France
Clinique Mathilde
Rouen, 76100, France
Clinique Armoricaine De Radiologie
Saint-Brieuc, F-22015, France
CHRU de Tours - Hopital Trousseau
Tours, 37044, France
Centre Hospitalier General Lucien Hussel
Vienne, 38200, France
Clinique du Tonkin
Villeurbanne, 69100, France
Related Publications (1)
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.
PMID: 26494856RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Martina Schneider
Federation Francophone de Cancerologie Digestive
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2008
First Posted
March 5, 2008
Study Start
January 1, 2007
Primary Completion
January 1, 2008
Study Completion
December 1, 2008
Last Updated
November 9, 2020
Record last verified: 2020-11