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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: | NCT00507585 |
PRIMARY
- To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every three weeks administered in combination with systemic intravenous Fluorouracil, Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the liver.
SECONDARY
Condition | Intervention | Phase |
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Liver Cancer |
Drug: Fluorouracil Drug: Avastin Drug: Leucovorin Drug: Oxaliplatin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic Fluorouracil, Leucovorin and Avastin for Patients With Advanced Solid Tumors Metastatic to the Liver |
Estimated Enrollment: | 81 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Oxaliplatin + Fluorouracil + Leucovorin + Avastin
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Drug: Fluorouracil
300 mg/m^2 IV Over 10 Minutes, then 600 mg/m^2 IV Over 22 Hours
Drug: Avastin
10 mg/m^2 IV Over 90 Minutes
Drug: Leucovorin
200 mg/m^2 IV Over 2 Hours
Drug: Oxaliplatin
60 mg/m^2 IV Over 2 Hours
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Apostolia M. Tsimberidou, MD, PhD | 713-792-4259 | |
Contact: Dwana Sanders | 713-794-1290 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Apostolia M. Tsimberidou, MD, PhD |
Principal Investigator: | Apostolia M. 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: | 2006-0160 |
Study First Received: | July 24, 2007 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00507585 |
Health Authority: | United States: Institutional Review Board |
Liver Cancer Hepatic Arterial Infusion Fluorouracil Avastin |
Leucovorin Oxaliplatin Bevacizumab |
Liver Neoplasms Oxaliplatin Liver Diseases Digestive System Diseases Digestive System Neoplasms |
Fluorouracil Liver neoplasms Leucovorin Gastrointestinal Neoplasms Bevacizumab |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients |