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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00529022 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention | Phase |
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Solid Tumors |
Drug: Azacitidine Drug: Valproic Acid Drug: Carboplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Azacitidine + Valproic Acid + Carboplatin
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Drug: Azacitidine
75 mg/m^2 Subcutaneous Injection or IV Daily x 5 Days
Drug: Valproic Acid
40 mg/kg PO Daily x 7 days
Drug: Carboplatin
AUC 2 IV Daily Over 60 Minutes
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Siqing Fu, MD, PhD | 713-792-9669 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Siqing Fu, MD, PhD |
Principal Investigator: | Siqing Fu, MD, PhD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Siqing Fu, MD, PhD/Assistant Professor ) |
Study ID Numbers: | 2007-0030 |
Study First Received: | September 11, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00529022 |
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 cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Carboplatin Ovarian Diseases |
Ovarian epithelial cancer Valproic Acid Fallopian Tube Neoplasms Genital Diseases, Female Azacitidine Fallopian tube cancer Endocrinopathy Endocrine Gland Neoplasms |
Antimetabolites Neurotransmitter Agents Antimetabolites, Antineoplastic Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antimanic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |