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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Celgene Corporation |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00529022 |
Purpose
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 are 2 phases in 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: Azacitidine Drug: Valproic Acid Drug: Carboplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Trial of Sequential Azacitidine and Valproic Acid Plus Carboplatin in the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer |
| Estimated Enrollment: | 65 |
| Study Start Date: | August 2007 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Azacitidine + Valproic Acid + Carboplatin |
Drug: Azacitidine
75 mg/m^2 Subcutaneous Injection or IV Daily x 5 Days
Other Names:
Drug: Valproic Acid
40 mg/kg PO Daily x 7 days
Other Name: Depakene
Drug: Carboplatin
AUC 2 by vein on Days 3 and 10 over 60 Minutes
Other Name: Paraplatin
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Gerald Falchook, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00529022 History of Changes |
| Other Study ID Numbers: | 2007-0030 |
| Study First Received: | September 11, 2007 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Advanced Cancer Solid Tumors Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Azacitidine 5-Azacitidine 5-Aza Vidaza™ |
5-AZC AZA-CR Ladakamycin NSC-102816 Vidaza Valproic Acid Depakene Carboplatin Paraplatin |
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Azacitidine Valproic Acid Carboplatin Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Anticonvulsants Central Nervous System Agents GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |