Azacitidine and Valproic Acid Plus Carboplatin in Patients With Ovarian Cancer
The goal of this clinical research study is to find out if giving azacitidine with valproic acid plus carboplatin can help control advanced cancer. The safety of this treatment will be studied as well. Researchers will also collect some extra blood samples for molecular marker studies (studies that may help researchers predict how participants respond to the combined therapy).
There were to be two phases of this study: a Phase 1 portion to find acceptable doses of the study drug combination, and a Phase 2 portion to study the response rates to the treatment schedule. The study did not proceed to the Phase 2 portion.
Drug: Valproic Acid
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Sequential Azacitidine and Valproic Acid Plus Carboplatin in the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer|
- Response Rate [ Time Frame: 8 weeks ]Assessment of tumor response by palpation, plain x-ray, MRI, or CT scan to be obtained after the first cycle and the every 2 cycles after that (8 weeks).
|Study Start Date:||August 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Azacitidine + Valproic Acid + Carboplatin
Azacitidine 75 mg/m^2 subcutaneous injection or by vein daily for 5 Days. Valproic Acid 40 mg/kg by mouth daily for 7 days. Carboplatin area under the curve (AUC) 2 by vein on Days 3 and 10 over 60 Minutes.
75 mg/m^2 Subcutaneous Injection or by vein Daily for 5 Days.
Other Names:Drug: Valproic Acid
40 mg/kg by mouth Daily for 7 days.
Other Name: DepakeneDrug: Carboplatin
AUC 2 by vein on Days 3 and 10 over 60 Minutes.
Other Name: Paraplatin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00529022
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gerald Falchook, MD||M.D. Anderson Cancer Center|