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Sponsors and Collaborators: |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy Merck |
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Information provided by: | Spanish Cooperative Group for Gastrointestinal Tumour Therapy |
ClinicalTrials.gov Identifier: | NCT00531115 |
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab plus XELOX for 4 cycles followed by maintenance treatment with cetuximab plus capecitabine as first line treatment in elderly patients with metastatic colorectal cancer
Condition | Intervention | Phase |
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Metastatic Colorectal Cancer |
Drug: cetuximab 5mg/ml |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicentre, Single-Arm, Phase II Study to Evaluate Safety and Efficacy of Cetuximab in Combination With Oxaliplatin and Capecitabine (XELOX) for 12 Weeks Followed by Maintenance Treatment With Cetuximab Plus Capecitabine as First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer. |
Estimated Enrollment: | 53 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Weekly administration of Cetuximab (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes) Oxaliplatin. 130 mg/m2 every three weeks. on day 1 for 4 cycles Capecitabine. 1000 mg/m2 twice daily (2.000 mg/m2 total daily dose) or 750 mg/m2 if Cl Cr=30-50 ml/min (1500 mg/m2 total daily dose) for two weeks (on days 1 to 14) followed by one week of rest (on days 15 to 21).
The patients will receive 4 cycles of cetuximab plus combination chemotherapy administered every 3 weeks in order to achieve a noticeable response. Then, oxaliplatin treatment will be stopped after a maximum of 4 infusions to prevent appearance of neuropathy and then followed by capecitabine 2 weeks out of 3, and cetuximab weekly as maintenance treatment.
Evaluations:
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients catalogued as delicate or "frail" for compliance with any of the following criteria
Contact: Inmaculada Ruiz de Mena | 00 34 91 378 82 75 | ttd@ttdgroup.org |
Spain | |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy | Recruiting |
Madrid, Spain, 28046 |
Study Chair: | Javier Sastre | H. Clínico San Carlos. Madrid |
Principal Investigator: | Jorge Aparicio | H. La Fe.Valencia |
Principal Investigator: | Enrique Aranda | H. Reina Sofía.Córdoba |
Principal Investigator: | Manuel Benavides | H. Carlos Haya. Málaga |
Principal Investigator: | Alfredo Carrato | H. Gral. Univ. de Elche. Alicante |
Principal Investigator: | Rosario Dueñas | H. Ciudad de Jaén. Jaén |
Principal Investigator: | Encarnación Gonzalez Flores | H. Virgen de las Nieves. Granada |
Principal Investigator: | Cristina Grávalos | H. Doce de Octubre. Madrid |
Principal Investigator: | Bartomeu Massutí | H. General. Alicante |
Principal Investigator: | Carlos Pericay | H. Parc Taulí. Barcelona |
Principal Investigator: | Margarita Reboredo | H. Juan Canalejo. La Coruña |
Principal Investigator: | Fernando Rivera | H. Marqués de Valdecilla. Santander |
Study Chair: | Eduardo Díaz-Rubio | H. Clínico San Carlos. Madrid |
Responsible Party: | Spanish Cooperative Group for Gastrointestinal Tumour Therapy ( Spanish Cooperative Group for Gastrointestinal Tumour Therapy ) |
Study ID Numbers: | TTD-06-05, EudraCT Nº: 2006-007062-11 |
Study First Received: | September 17, 2007 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00531115 |
Health Authority: | Spain: Spanish Agency of Medicines |
metastatic colorectal cancer elderly patients cetuximab, oxaliplatin, capecitabine |
Oxaliplatin Capecitabine Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Cetuximab |
Colonic Diseases Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |