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Sponsors and Collaborators: |
Unidad Integral de Investigación en Oncología S.L. Hoffmann-La Roche |
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Information provided by: | Unidad Integral de Investigación en Oncología S.L. |
ClinicalTrials.gov Identifier: | NCT00345696 |
The purpose of this study is to determinate the free survival to disease progression at 9 months of treatment.
Condition | Intervention | Phase |
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Metastatic Colorectal Cancer |
Drug: Bevacizumab Drug: Capecitabine Drug: Oxaliplatine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of First Line Capecitabine Administered on Continuous Way Combined With Oxaliplatin and Bevacizumab Every Two Weeks in Metastatic Colorectal Cancer Patients. |
Estimated Enrollment: | 32 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
To look for a new chemotherapy management to get less acute and chronic toxicity and/or an easier administration treatment line.
This study tries to demonstrate an alternative chemotherapy scheme,continuous polychemotherapy regimen with less dose with the added effect of the monoclonal antibody Bevacizumab.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Absolute neutrophils count (ANC) < 1.5 x 109/l. Platelet count < 100 x 109/l. Hemoglobin < 9 g/dl. INR > 1.5. Total bilirubin > 1.5 ULN. ALT and/or AST > 2.5 x ULN or > 5 x ULN (in case of hepatic metastasis). Alkaline phosphatase > 2.5 x ULN or >5 x ULN (in case of hepatic metastasis), or > 10 x ULN (in case of bone metastasis).
Contact: Cristina Grávalos, MD | + 34 650 770 415 | cgravalos@telefonica.net |
Contact: Itziar Caldevilla, Pharmacist | + 34 902884102 | i.caldevilla@dynasolutions.com |
Spain | |
Hospital 12 de Octubre | |
Madrid, Spain, 28041 |
Study Chair: | Cristina Grávalos, MD | Unidad Integral de Investigación en Oncología S.L. |
Principal Investigator: | Cristina Grávalos, MD | Hospital 12 de Octubre |
Study ID Numbers: | XELOXAVBISEMANAL |
Study First Received: | June 27, 2006 |
Last Updated: | June 27, 2006 |
ClinicalTrials.gov Identifier: | NCT00345696 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Capecitabine Oxaliplatin Bevacizumab First line |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents |
Growth Inhibitors Capecitabine Digestive System Neoplasms Growth Substances Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |