Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, Leucovorin, and Avastin
|ClinicalTrials.gov Identifier: NCT00507585|
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : July 30, 2012
- 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.
- To document in a descriptive fashion the antitumor efficacy of this combination regimen.
- To evaluate the feasibility and accuracy of an alternate radiographic assessment tool and compare with available tumor markers and RECIST guidelines.
- To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Advanced Solid Tumors||Drug: Fluorouracil Drug: Avastin Drug: Leucovorin Drug: Oxaliplatin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2006|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
|Experimental: Oxaliplatin + Fluorouracil + Leucovorin + Avastin||
300 mg/m^2 IV over 10 Minutes, then 600 mg/m^2 IV over 22 Hours repeated every 3 weeks (1 Cycle).
Other Names:Drug: Avastin
10 mg/m^2 IV Over 90 Minutes repeated every 3 weeks (1 Cycle).
Other Name: BevacizumabDrug: Leucovorin
200 mg/m^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).Drug: Oxaliplatin
60 mg/m^2 IV Over 2 Hours repeated every 3 weeks (1 Cycle).
- To study the highest tolerable dose of oxaliplatin used in combination with 5-fluorouracil, leucovorin, and Avastin® (bevacizumab) for patients with advanced cancer that has spread to the liver. [ Time Frame: 5 Years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507585
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Apostolia M. Tsimberidou, MD, PhD||M.D. Anderson Cancer Center|