A Pilot, Phase II, Single Center, Non-comparative, Open-label Study of Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate toxicities
Michael Fung Kee Fung, MD
Canada: Health Canada