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Azacitidine and Valproic Acid Plus Carboplatin in Patients With Ovarian Cancer
This study is ongoing, but not recruiting participants.

First Received on September 11, 2007.   Last Updated on May 22, 2012   History of Changes
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 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). ] [ Designated as safety issue: Yes ]

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:
  • 5-Azacitidine
  • 5-Aza
  • Vidaza™
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
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
Criteria

Inclusion Criteria:

  1. Patient has histologically or cytologically confirmed diagnosis of advanced solid tumor (that has progressed following standard therapy or for whom, in the opinion of the investigator, no standard effective therapy is available) during the phase I study. Only patients who have platinum resistant epithelial carcinoma of the ovary, fallopian tube or primary peritoneal carcinoma are enrolled onto the phase II study. According to standard GOG criteria platinum resistant is defined to have had a disease-free interval of shorter than 6 months following platinum treatment.
  2. Patient has measurable or evaluable disease by radiological imaging techniques with documented progression within 1 month before study entry or disease that has not responded to treatment. (Pleural effusions, ascites, osseous metastasis, elevation of tumor marker and lesions located in previously irradiated areas are not considered measurable).
  3. Patient is willing to comply with study procedures to have blood collections for correlative studies.
  4. Patient has an ECOG performance status of 0-2.
  5. Patient must be informed of the investigational nature of this study and must sign and give written IRB approved informed consent in accordance with institutional guidelines.
  6. If patient is of child-bearing potential, she or he has agreed to practice an effective method of birth control during the study and up to 3 months after the last treatment.
  7. Patient has adequate liver and renal function: serum albumin =/>3.0 g/dL; serum bilirubin =/<2.0 mg/dL; ALT=/<3x upper limit of normal (uln); and serum creatinine =/< 2.0 mg/dL or a calculated creatinine clearance of at least 40 ml/min.
  8. Patient has adequate bone marrow reserve. ANC=/>1,500/ul, Platelet count =/>100,000/ul, and Hemoglobin =/>9.0g/dL.

Exclusion Criteria:

  1. Any concurrent chemotherapy.
  2. Underlying medical condition that might be aggravated by treatment or that cannot be controlled, such as active uncontrolled serious infection and cardiac dysfunction.
  3. Medical and psychiatric problems of sufficient severity to limit full compliance with the study or expose patients to undue risk.
  4. Known hypersensitivity to azacitidine, valproic acid, carboplatin or their analogs.
  5. Failure to recover from any prior surgery within 4 weeks of study entry.
  6. Pregnant or lactating.
  7. Any treatment specific for tumor control within 3 weeks of dosing with study drugs (within 2 weeks if given weekly or within 6 weeks for nitrosoureas or mitomycin C) or failure to recover from the toxic effect of any of these therapies prior to study entry. Any investigational drug within 30 days of first day of dosing.
  8. Any signs of intestinal obstruction interfering with nutrition or oral intake.
  9. History of CNS metastasis unless the patient has had surgery or radiation, and does not require oral or intravenous corticosteroids or anticonvulsants.
  10. Advanced malignant hepatic tumors that are defined as the total hepatic metastases more than 25% of hepatic parenchyma.
  11. History of high dose chemotherapy for ovarian cancer in phase II study. High dose chemotherapy is defined as the intensity and/or the density of a chemotherapeutic agent that are beyond standard of care for ovarian cancer treatment.
  12. History of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease free for at least two years in phase II study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529022

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Gerald Falchook, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 22, 2012