Azacitidine and Valproic Acid Plus Carboplatin in Patients With Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT00529022|
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : February 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: Azacitidine Drug: Valproic Acid Drug: Carboplatin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Sequential Azacitidine and Valproic Acid Plus Carboplatin in the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529022
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gerald Falchook, MD||M.D. Anderson Cancer Center|