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Paclitaxel, Carboplatin and Vorinostat for the Treatment of Advanced Stage Ovarian Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00976183
Recruitment Status : Terminated (toxicities)
First Posted : September 14, 2009
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gynecologic Oncology Associates

Brief Summary:
Since the mortality rates for patients with advanced ovarian carinoma are high, the most likely way to improve progression free and overall survival is with maximal "upfront" therapy (Morrow & Curtin, 1998). Currently, no triplet regimen has demonstrated compelling superiority. Therefore, the combination of Paclitaxel, Carboplatin, and Vorinostat is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.

Condition or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: Vorinostat Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Non-Randomized, Pilot Study of Weekly Paclitaxel, Every Four-week Carboplatin and Oral Vorinostat for Patients Newly Diagnosed With Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
Study Start Date : October 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Experimental: Vorinostat
All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.
Drug: Vorinostat
Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.
Other Name: suberoylanilide hydroxamic acid (SAHA)

Drug: Vorinostat
Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Other Name: suberoylanilide hydroxamic acid (SAHA)




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 2 years or 24 months ]
    Clinical response was assessed by clinical, serologic, and radiographic means.


Secondary Outcome Measures :
  1. Number of Participants With Progression Free Survival (PFS) up to 24 Months [ Time Frame: 2 years or 24 months ]
    Progression-free survival was defined as the length of time from the date of initial induction chemotherapy until clinical, radiological, or CA-125 progression



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
  • Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
  • If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
  • Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.
  • Karnofsky performance status > 50%.
  • Subjects who have signed an institutional review board (IRB) approved informed consent form.

Exclusion Criteria:

  • Subjects with epithelial ovarian cancer of low malignancy potential.
  • Subjects with septicemia, severe infection, or acute hepatitis.
  • Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976183


Locations
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United States, California
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
Sponsors and Collaborators
Gynecologic Oncology Associates
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: John Micha, MD Gynecologic Oncology Associates
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Responsible Party: Gynecologic Oncology Associates
ClinicalTrials.gov Identifier: NCT00976183    
Other Study ID Numbers: GOA-TCOV
First Posted: September 14, 2009    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: August 2016
Keywords provided by Gynecologic Oncology Associates:
ovarian cancer
gynecologic oncology
vorinostat
treatment
Additional relevant MeSH terms:
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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
Vorinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action