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Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00628810
First received: March 4, 2008
Last updated: February 6, 2009
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Biological: bevacizumab
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response at 6 months by RECIST [ Designated as safety issue: No ]
  • Tolerability by NCI CTC v. 2.0 criteria [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free and overall survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Quality of life using the EuroQOL EQ5D questionnaire [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: January 2007
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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic adenocarcinoma of the colon or rectum

    • Not curable by surgery
  • Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/ UGT1A1*28
  • Measurable disease
  • No original tumor in place
  • No secondary cerebral metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628810

Locations
France
Centre Hospitalier d'Abbeville Recruiting
Abbeville, France, 80101
Contact: Mathieu Pauwels    33-3-2225-5325      
Centre Hospitalier Universitaire d'Amiens Recruiting
Amiens, France, 80054
Contact: Jean-Paul Joly    33-3-2266-8214      
Hopital Duffaut Recruiting
Avignon, France, 84902
Contact: Ahmed Azzedine    33-4-3275-3121      
C.H.G. Beauvais Recruiting
Beauvais, France, 60021
Contact: Suzanne Nguyen, MD    33-34-411-2309    s.nguyen@ch-beauvais.fr   
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Anne-Claire Dupont-Gossart    33-81-668-240      
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33300
Contact: Cedric Lecaille    33-556-437-354      
Hopital Ambroise Pare Recruiting
Boulogne-Billancourt, France, F-92104
Contact: Emmanuel Mitry, MD, PhD    33-1-4909-5874      
Centre Hospitalier Pierre Oudot Recruiting
Bourgoin-Jallieu, France, 38300
Contact: Noel Stremsdoerfer, MD    33-4-7427-3011      
Centre Hospitalier General Recruiting
Brive, France, 19101
Contact: Laure Vayre    33-55-926-000      
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Karine Bouhier    33-2-3145-5000      
CHU de Caen Recruiting
Caen, France, 14033
Contact: Karine Bouhier    33-231-063-106      
Centre Hospitalier de Chalons-en-Champagne Recruiting
Chalons-en-Champagne, France, 51000
Contact: Naceur Abdelli, MD    33-3-2669-6051      
Hopitaux Civils de Colmar Recruiting
Colmar, France, 68024
Contact: Gilles Breysacher, MD    33-3-8912-6097    gilles.breysacher@ch-colmar.rss   
Federation Francophone de Cancerologie Digestive Recruiting
Dijon, France, 21079
Contact: Martina Schneider    33-3-8039-3483      
Hopital Du Bocage Recruiting
Dijon, France, 21034
Contact: Laurent Bedenne, MD    33-3-8029-3750    lbedenne@u-bourgogne.fr   
Clinique Saint Vincent Recruiting
Epernay, France, 51200
Contact: Patrick Geoffroy    33-3-2659-6135      
Centre Hospitalier Departemental Recruiting
La Roche Sur Yon, France, F-85025
Contact: Roger Faroux    33-2-5144-6168      
Hopital Andre Mignot Recruiting
Le Chesnay, France, 78157
Contact: Christine Abraham, MD    33-1-3963-8909      
Centre Hospitalier Universitaire de Bicetre Recruiting
Le Kremlin Bicetre, France, 94275
Contact: Anne Thirot-Bidault    33-1-4521-2121      
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Jean-Francois Seitz, MD    33-4-9138-6023      
CHU Nord Recruiting
Marseille, France, 13915
Contact: Mohamed Gasmi, MD    33-4-9196-8737      
Hopital de l'Archet CHU de Nice Recruiting
Nice, France, F-06202
Contact: Francois X. Caroli-Bosc    33-4-9203-6021      
CHR D'Orleans - Hopital de la Source Recruiting
Orleans, France, 45100
Contact: Jean-Paul Lagasse    33-02-3651-4704      
Hopital Bichat - Claude Bernard Recruiting
Paris, France, 75018
Contact: Thomas Aparicio    33-1-4025-7200    thomas.aparicio@bch.ap-hop-paris.fr   
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Bruno Landi, MD    33-1-5609-3555    bruno.landi@egp.aphp.fr   
CHU - Robert Debre Recruiting
Reims, France, 51092
Contact: Olivier Bouche, MD, PhD    33-3-2678-7169    obouche@chu-reims.fr   
Clinique Mathilde Recruiting
Rouen, France, 76100
Contact: Nicolas Albin, MD    33-2-3281-1010      
Hopital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: Pierre Michel    33-2-3288-8260      
Clinique Armoricaine De Radiologie Recruiting
Saint Brieuc, France, F-22015
Contact: Pierre-Luc Etienne, MD    33-2-9675-22      
CHRU de Tours - Hopital Trousseau Recruiting
Tours, France, 37044
Contact: Thierry Lecomte, MD    33-2-4747-5900    lecomt.t@med.univ-tours.fr   
Centre Hospitalier General Lucien Hussel Recruiting
Vienne, France, 38200
Contact: Beatrice Eymard-Rey, MD    33-4-7431-3376    b.eymard-rey@ch-vienne.fr   
Clinique du Tonkin Recruiting
Villeurbanne, France, 69100
Contact: Estelle Louet    33-4-7282-6722      
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
Study Chair: Martina Schneider Federation Francophone de Cancerologie Digestive
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00628810     History of Changes
Other Study ID Numbers: CDR0000564065, FFCD-0504, EUDRACT-2006-003157-25, EU-20755
Study First Received: March 4, 2008
Last Updated: February 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon
adenocarcinoma of the rectum
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Irinotecan
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Fluorouracil
Levoleucovorin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014