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Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer

NCT00261027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-03-02

No results posted yet for this study

Summary

This project is a pilot, phase II, open-label, single-center, non-comparative clinical study evaluating the antitumor efficacy and tolerability of exemestane in treating adult post-menopausal women with recurrent or refractory, stage II-IV, epithelial ovarian cancer.

To evaluate the efficacy and tolerability of exemestane in this population, patients will be enrolled at a single site, namely the Ottawa Regional Cancer Center. Patients selected according to the criteria outlined will receive exemestane (25 mg/day given orally once daily) until disease progression or until study withdrawal. These patients will be treated on an out-patient basis. There is no specific wash-out time required for patients who have previously received either cis or carboplatinum; however, this previous therapy must stop upon patient inclusion into this trial.

In 1st stage if less than 2/15 patients achieve a response then study will be terminated. In 2nd stage if greater than 7/28 patients achieve a response then no further investigation of the drug is warranted.Treatment (including drug dosages) A commercial supply of exemestane (Aromasin) will be provided. The medication will be administered by the patient at home (25 mg taken orally once daily until disease progression) The medication should be taken each day after a meal at the same time of the day. There are no patient diaries and no need for the patient to record the time of administration.

Conditions

Interventions

DRUG

Exemestane

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Michael Fung Kee Fung, MD · OHRI

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2007-07-31
Completion
2007-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261027 on ClinicalTrials.gov