NCT00091195

Brief Summary

This phase II trial is studying how well depsipeptide (romidepsin) works in treating patients with recurrent ovarian epithelial or peritoneal cavity cancer. Drugs used in chemotherapy, such as depsipeptide (romidepsin), work in different ways to stop tumor cells from dividing so they stop growing or die. Depsipeptide (romidepsin) may also stop the growth of ovarian epithelial or peritoneal cavity cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2004

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

2.5 years

First QC Date

September 7, 2004

Last Update Submit

March 18, 2013

Conditions

Primary Peritoneal Cavity CancerRecurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (4)

  • Response rate

    Estimated as proportion of patients with complete or partial reduction in tumor burden.

    Up to 5 years

  • Toxicity as assessed by CTCAE version 3.0

    Up to 5 years

  • Time to progression

    From first treatment until the date of progression, assessed up to 5 years

  • Survival

    From first treatment until death or the last date of contact, assessed up to 5 years

Study Arms (1)

Treatment (single-agent depsipeptide)

EXPERIMENTAL

Patients receive depsipeptide (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: romidepsin

Interventions

romidepsinDRUG
Also known as: FK228, FR901228, Istodax
Treatment (single-agent depsipeptide)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed primary ovarian epithelial or peritoneal cavity cancer
  • Histologic confirmation of recurrent disease not required
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, computed tomography \[CT\] scan, or magnetic resonance imaging \[MRI\]) OR ≥ 10 mm by spiral CT scan
  • Achieved a complete response after initial prior platinum-containing (cisplatin or carboplatin) chemotherapy regimen (e.g., conventional-dose therapy, high-dose therapy, consolidation therapy, or extended therapy after surgical or nonsurgical assessment)
  • Patients who have not received paclitaxel or docetaxel as initial therapy may receive a second regimen containing these drugs
  • No prior chemotherapy for persistent or recurrent disease, including re-treatment with the original regimen
  • Platinum-sensitive disease, defined as having a treatment-free interval with no evidence of progressive disease for \> 6 but \< 12 months after completion of a platinum-based regimen
  • No known brain metastases
  • Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
  • Performance status - Karnofsky 60-100%
  • More than 6 months
  • White blood cells (WBC) ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin normal
  • +41 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

High Point Regional Hospital

High Point, North Carolina, 27261, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

romidepsin

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

Study Officials

  • Brigitte Miller

    Wake Forest University Health Sciences

    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

September 7, 2004

First Posted

September 9, 2004

Study Start

September 1, 2004

Primary Completion

March 1, 2007

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(2)