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Sponsored by: |
Gruppo Oncologico del Nord-Ovest |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00719797 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan, oxaliplatin, leucovorin, and fluorouracil, 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.
Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens given together with bevacizumab to see how well they work as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: bevacizumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Phase III Randomized Trial of FOLFOXIRI + Bevacizumab Versus FOLFIRI + Bevacizumab as First- Line Treatment for Metastatic Colorectal Cancer. |
Estimated Enrollment: | 450 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (FOLFOXIRI): Experimental
Patients receive irinotecan hydrochloride IV over 1 hour, oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1. |
Biological: bevacizumab
Given IV
Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
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Arm II (FOLFIRI): Experimental
Patients receive irinotecan hydrochloride IV over 1 hour, leucovorin calcium IV over 2 hours, and bevacizumab IV on day 1. Patients also receive fluorouracil IV continuously over 48 hours beginning on day 1.
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Biological: bevacizumab
Given IV
Drug: fluorouracil
Given IV
Drug: irinotecan hydrochloride
Given IV
Drug: leucovorin calcium
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2), prior adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
Patients undergo serum extraction and blood sample collection periodically for genotyping studies. Patients also undergo collection of tumoral sections from paraffin embedded primary and/or metastatic lesions periodically for immunohistochemical analyses.
After completion of study treatment, patients are followed every 8 weeks.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Clinically significant (i.e., active) cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Italy | |
A. Perrino Hospital | Recruiting |
Brindisi, Italy, 72100 | |
Contact: Contact Person 39-831-537-508 | |
Arcispedale S. Maria Nuova | Recruiting |
Reggio Emilia, Italy, 42100 | |
Contact: Contact Person 39-522-29-66-23 | |
Azienda Istituti Ospitalieri | Recruiting |
Cremona, Italy, 26100 | |
Contact: Contact Person 39-372-40-51-11 | |
Azienda Ospedaliera di Firenze | Recruiting |
Florence, Italy, 50011 | |
Contact: Contact Person 39-552-49-64-76 | |
Azienda Ospedaliera Maggiore Della Carita | Recruiting |
Novara, Italy, 28100 | |
Contact: Contact Person 39-32-13-73-32-82 | |
Azienda Ospedaliera Universitaria Senese | Recruiting |
Siena, Italy, 53100 | |
Contact: Contact Person 39-577-58-51-11 | |
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Recruiting |
Turin, Italy, 10126 | |
Contact: Contact Person 39-11-63-31-633 | |
Azienda Usl 8 Arezzo | Recruiting |
Arezzo, Italy, 52100 | |
Contact: Contact Person 39-575-2551 | |
Azienda USL12 Versilia | Recruiting |
Lido di Camaiore, Italy, 55043 | |
Contact: Contact Person 39-584-60-51-0 | |
Universita Politecnica Delle Marche | Recruiting |
Ancona, Italy, 60100 | |
Contact: Contact Person 39-71-220-2318 | |
Civic Hospital of Carrara | Recruiting |
Carrara, Italy, 54033 | |
Contact: Contact Person 39-585-7671 | |
Istituto Nazionale per la Ricerca sul Cancro | Recruiting |
Genoa, Italy, 16132 | |
Contact: Contact Person 39-10-56-001 | |
Istituto Scientifico H. San Raffaele | Recruiting |
Milan, Italy, 20132 | |
Contact: Contact Person 39-2-26-43-27-54 | |
Misericordia e Dolce Hospital | Recruiting |
Prato, Italy, 59100 | |
Contact: Contact Person 39-574-43-47-66 | |
Ospedale Pistoia | Recruiting |
Pistoia, Italy, Pistoia | |
Contact: Contact Person 39-573-3521 | |
Ospedale Santa Croce | Recruiting |
Cuneo, Italy, 12100 | |
Contact: Contact Person 39-171-44-13-09 | |
Ospendale S. Andrea EST | Recruiting |
La Spezia, Italy, 19100 | |
Contact: Contact Person 39-187-53-33-15 | |
Presidio Ospedaliero di Livorno | Recruiting |
Livorno, Italy, 57100 | |
Contact: Contact Person 39-58-622-3189 | |
Centro di Riferimento Oncologico - Aviano | Recruiting |
Aviano, Italy, 33081 | |
Contact: Contact Person 39-43-46-59-111 |
Principal Investigator: | Alfredo Falcone, MD | Presidio Ospedaliero di Livorno |
Study ID Numbers: | CDR0000598582, GONO-TRIBE, ASL608LIOM04, EUDRACT:2008-001537-10 |
Study First Received: | July 19, 2008 |
Last Updated: | February 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00719797 History of Changes |
Health Authority: | Unspecified |
stage IV rectal cancer stage IV colon cancer stage III rectal cancer stage III colon cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Irinotecan Leucovorin Bevacizumab Rectal Diseases Oxaliplatin Vitamins Micronutrients Digestive System Neoplasms Vitamin B Complex |
Rectal Neoplasm Trace Elements Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Camptothecin Calcium, Dietary Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Irinotecan Leucovorin Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins |
Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Angiogenesis Inhibitors Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms |