Azacitidine and Valproic Acid Plus Carboplatin in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00529022
First received: September 11, 2007
Last updated: February 19, 2013
Last verified: February 2013
  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 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 Intervention Phase
Solid Tumors
Drug: Azacitidine
Drug: Valproic Acid
Drug: Carboplatin
Phase 1

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 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: 8 weeks ] [ Designated as safety issue: No ]
    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).


Enrollment: 36
Study Start Date: August 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Azacitidine
75 mg/m^2 Subcutaneous Injection or by vein Daily for 5 Days.
Other Names:
  • 5-Azacitidine
  • 5-Aza
  • Vidaza™
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
Drug: Valproic Acid
40 mg/kg by mouth Daily for 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 2 study, if progresses to phase 2. According to standard Gynecologic Oncology Group (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 Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  5. Patient must be informed of the investigational nature of this study and must sign and give written Internal Review Board (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; alanine aminotransferase (ALT) =/<3* 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. Absolute neutrophil count (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 central nervous system (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 2 of the study, if Phase 2 of study needed. 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 2 study, if Phase 2 of study needed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: February 19, 2013
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
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Azacitidine
Carboplatin
Valproic Acid
Anticonvulsants
Antimanic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014