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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00265824 |
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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving combination chemotherapy together with bevacizumab and erlotinib is more effective than giving combination chemotherapy together with bevacizumab in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy, bevacizumab, and erlotinib to see how well they work compared to combination chemotherapy and bevacizumab in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
Colorectal Cancer |
Drug: bevacizumab Drug: capecitabine Drug: erlotinib hydrochloride Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Study of an Optimized Chemotherapy + Avastin Strategy ± Tarceva in Metastatic Colorectal Cancer |
Estimated Enrollment: | 640 |
Study Start Date: | May 2005 |
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven metastatic adenocarcinoma of colon or rectum
PATIENT CHARACTERISTICS:
No clinically significant (i.e. active) cardiovascular disease including any the following:
PRIOR CONCURRENT THERAPY:
No previous chemotherapy and/or immunotherapy for metastatic disease
France | |||||
C.H. Senlis | Recruiting | ||||
Senlis, France, 60309 | |||||
Contact: Elisabeth Carola, MD 33-3-4421-7026 | |||||
Clinique Saint Jean | Recruiting | ||||
Lyon, France, 69008 | |||||
Contact: Gerard Lledo 33-4-7878-1051 | |||||
Clinique Victor Hugo | Recruiting | ||||
Le Mans, France, F-72000 | |||||
Contact: Gerard Ganem, MD 33-2-4339-1300 | |||||
Hopital Drevon | Recruiting | ||||
Dijon, France, 21000 | |||||
Contact: Michel Flesch, MD 33-3-8036-4822 | |||||
Hopital Europeen Georges Pompidou | Recruiting | ||||
Paris, France, 75015 | |||||
Contact: Bruno Landi, MD 33-1-5609-3555 bruno.landi@egp.aphp.fr | |||||
Hopital Foch | Recruiting | ||||
Suresnes, France, 92151 | |||||
Contact: May Mabro, MD 33-1-4625-2168 m.mabro@hopital-foch.org | |||||
Polyclinique De Courlancy | Recruiting | ||||
Reims, France, F-51100 | |||||
Contact: Philippe Colin, MD 33-3-2684-0284 colin.courlancy@wanadoo.fr | |||||
Hopital Saint Antoine | Recruiting | ||||
Paris, France, 75571 | |||||
Contact: Christophe Tournigand 33-1-4928-2329 christophe.tournigand@sat.ap-hop-paris.fr | |||||
Hopital Tenon | Recruiting | ||||
Paris, France, 75970 | |||||
Contact: Thierry Andre, MD 33-1-6177-0708 thierry.andre@tnn.ap-hop-paris.fr | |||||
Institut Claudius Regaud | Recruiting | ||||
Toulouse, France, 31052 | |||||
Contact: Jean-Pierre Delord, MD, PhD 33-5-6142-4114 delord.jean-pierre@claudiusregaud.fr | |||||
Institut Sainte Catherine | Recruiting | ||||
Avignon, France, 84000 | |||||
Contact: Laurent Mineur, MD 33-4-9027-6397 | |||||
Intercommunal Hospital | Recruiting | ||||
Montfermeil, France, 93370 | |||||
Contact: Mostefa Bennamoun, MD 33-1-4850-1808 | |||||
Hopital Robert Boulin | Recruiting | ||||
Libourne, France, 33500 | |||||
Contact: Dominique Auby 33-5-5755-3552 dominique.auby@cheibourne.aquisante.fr |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
Investigator: | Aimery de Gramont, MD | Hopital Saint Antoine |
Study Chair: | Christophe Tournigand | Hopital Saint Antoine |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000453861, GERCOR-C04-2, EU-20565, GERCOR-OPTIMOX3-TARCEVA, ROCHE-GERCOR-C04-2, GERCOR-DREAM- C04-2 |
First Received: | December 14, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00265824 |
Health Authority: | Unspecified |
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