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Spots Global Cancer Trial Database for Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Official Title: 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

Study ID: NCT00628810

Study Description

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.

Detailed Description: OBJECTIVES: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, Besancon, , France

Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France

Hopital Ambroise Pare, Boulogne-Billancourt, , France

Centre Hospitalier Pierre Oudot, Bourgoin-Jallieu, , France

Centre Hospitalier General, Brive, , France

CHU de Caen, Caen, , France

Centre Regional Francois Baclesse, Caen, , France

Centre Hospitalier de Chalons-en-Champagne, Chalons-en-Champagne, , France

Hopitaux Civils de Colmar, Colmar, , France

Hopital Du Bocage, Dijon, , France

Federation Francophone de Cancerologie Digestive, Dijon, , France

Clinique Saint Vincent, Epernay, , France

Centre Hospitalier Departemental, La Roche Sur Yon, , France

Hopital Andre Mignot, Le Chesnay, , France

Centre Hospitalier Universitaire de Bicetre, Le Kremlin Bicetre, , 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, Orleans, , 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

Contact Details

Name: Martina Schneider

Affiliation: Federation Francophone de Cancerologie Digestive

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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