NCT00976183

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

September 10, 2009

Results QC Date

August 9, 2016

Last Update Submit

February 24, 2017

Conditions

Ovarian Neoplasms

Keywords

ovarian cancergynecologic oncologyvorinostattreatment

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Clinical response was assessed by clinical, serologic, and radiographic means.

    2 years or 24 months

Secondary Outcomes (1)

  • Number of Participants With Progression Free Survival (PFS) up to 24 Months

    2 years or 24 months

Study Arms (1)

Vorinostat

EXPERIMENTAL

All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.

Drug: Vorinostat

Interventions

VorinostatDRUG

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.

Also known as: suberoylanilide hydroxamic acid (SAHA)
Vorinostat

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Associates

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Results Point of Contact

Title
John P. Micha, M.D.
Organization
Gynecologic Oncology Associates
Research@gynoncology.com
949-642-5165

Study Officials

  • John Micha, MD

    Gynecologic Oncology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 14, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2016-08

Locations

US(1)