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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00491855 |
Primary Objectives:
Condition | Intervention | Phase |
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Peritoneal Cancer |
Drug: Bevacizumab Drug: Oxaliplatin Drug: Paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis |
Estimated Enrollment: | 72 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bevacizumab + Oxaliplatin + Paclitaxel
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Drug: Bevacizumab
Starting dose level 2.5 mg/kg given intravenously on day 1.
Drug: Oxaliplatin
Starting dose level 25 mg/m^2 given intraperitoneally on day 2.
Drug: Paclitaxel
Starting dose level 110 mg/m^2 given continuous infusion on day 1 and 30 mg/m^2 given intraperitoneally on day 8.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Apostolia Tsimberidou, MD, PhD | 713-792-4259 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Apostolia Tsimberidou, MD, PhD |
Principal Investigator: | Apostolia Tsimberidou, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Apostolia M. Tsimberidou MD, PhD/Assistant Professor ) |
Study ID Numbers: | 2006-1068 |
Study First Received: | June 25, 2007 |
Last Updated: | March 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00491855 History of Changes |
Health Authority: | United States: Institutional Review Board |
Advanced Peritoneal Carcinomatosis Peritoneal Cancer Bevacizumab Avastin Anti-VEGF monoclonal antibody |
rhuMAb-VEGF Oxaliplatin Eloxatin Paclitaxel Taxol |
Digestive System Neoplasms Immunologic Factors Antimitotic Agents Bevacizumab Abdominal Neoplasms Angiogenesis Inhibitors Carcinoma Antibodies, Monoclonal Oxaliplatin Antibodies |
Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Antineoplastic Agents, Phytogenic Immunoglobulins Neoplasms, Glandular and Epithelial |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Antibodies, Monoclonal Oxaliplatin Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Neoplasms by Histologic Type Digestive System Neoplasms |
Growth Substances Mitosis Modulators Antimitotic Agents Abdominal Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |