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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00132067
Other study ID # NCI-2012-02667
Secondary ID NCI-2012-02667GO
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2005
Est. completion date July 2008

Study information

Verified date July 2019
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
vorinostat
Given orally

Locations

Country Name City State
United States Gynecologic Oncology Group Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Toxicity as assessed by CTCAE v 3.0 Up to 5 years after completion of study treatment
Secondary Clinical response (partial and complete response) rate as according to RECIST s Up to 5 years
Secondary Duration of PFS From study entry until disease progression, death or date of last contact., assessed up to 5 years
Secondary Duration of survival From entry into the study to death or the date of last contact, assessed up to 5 years
See also
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Completed NCT00049556 - Gefitinib in Treating Patients With Cervical Cancer Phase 2
Terminated NCT00028782 - EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer N/A
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Completed NCT00003670 - Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer Phase 2
Completed NCT00003998 - Carboplatin Plus Paclitaxel or Docetaxel in Treating Patients With Ovarian Epithelial Cancer Phase 3
Completed NCT00003345 - Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Phase 2