NCT00132067

Brief Summary

This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

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

August 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

August 16, 2005

Last Update Submit

July 22, 2019

Conditions

Primary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival (PFS)

    Time at risk will be assessed from the date of registration onto the study and include all eligible patients who receive any study treatment. An analysis of any potential treatment effect on PFS may be conducted against the historical controls provided in GOG 126 and GOG 146 using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.

    At 6 months

  • Toxicity as assessed by CTCAE v 3.0

    Up to 5 years after completion of study treatment

Secondary Outcomes (3)

  • Clinical response (partial and complete response) rate as according to RECIST s

    Up to 5 years

  • Duration of PFS

    From study entry until disease progression, death or date of last contact., assessed up to 5 years

  • Duration of survival

    From entry into the study to death or the date of last contact, assessed up to 5 years

Study Arms (1)

Treatment (vorinostat)

EXPERIMENTAL

Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: vorinostat

Interventions

vorinostatDRUG

Given orally

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Treatment (vorinostat)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
  • Recurrent or persistent disease
  • Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease
  • Initial treatment may have included high-dose, consolidation, noncytotoxic agents, or extended therapy administered after surgical or non-surgical assessment
  • Treatment-free interval after completion of platinum-based chemotherapy must have been \< 12 months
  • Measurable disease, defined as ≥ 1 unidimensionally measurable target\* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
  • Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
  • No known brain metastases
  • Performance status - GOG 0-1
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian 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

Study Officials

  • Susan Modesitt

    Gynecologic Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 19, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2006

Study Completion

July 1, 2008

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

US(1)