Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, Leucovorin, and Avastin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||January 2010|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|