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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

Phase 2
20 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- · Patients aged 18 years or older with a documented diagnosis of metastatic, stage
II-IV, epithelial ovarian cancer and a histological/cytological confirmation of
disease.· Patients must be oophorectomized or be post-menopausal (i.e. no menses
within the last 12 months).· Patients should have objective evidence of measurable
disease according to the modified RECIST guidelines. If no measurable disease is
present, there must be a CA 125 level of ³ 30 U/mL in combination with non-measurable
disease and/or ascites.· Patients may be designated:· First line - patients who have
either refused or did not qualify for initial therapy with standard cis- or
carboplatin + paclitaxel.· Refractory - progression while on chemotherapy, or relapse
within 12 months of final chemotherapy (with a maximum of 2 lines of chemotherapy
treatment)· Recurrent - relapse beyond 12 months of final chemotherapy (with a
maximum of 2 lines of chemotherapy treatment)· In patients having received radiation
therapy, at least 4 weeks must have passed subsequent to the cessation of the
radiation therapy, prior to the baseline assessment in this study.· Patients with
ECOG performance status of 0, 1 or 2 and a life expectancy of > 3 months.·
Patients must have adequate haematological (WBC ³ 4000/mL, neutrophils ³ 2000/mL,
platelets ³ 100,00/mL), hepatic (total bilirubin £ 1.5 x upper limit normal (ULN),
AST/ALT £ 3 x ULN)) and renal (serum creatinine < 1.5 X ULN) organ functions.·
Patients must give written informed consent signed prior to registration.

Exclusion Criteria:

- Known hypersensitivity to exemestane· Participation in another clinical study within
thirty days prior to the treatment on this study. Concurrent treatment with other
experimental drugs or anticancer therapy.· Patients with rapidly progressive disease
for which hormonal therapy may not be indicated.· Concomitant malignancies except for
adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell
carcinoma of the skin. Patients with other malignancies must be disease free for at
least 5 years.· Patients with metastatic disease of the central nervous system, eg.
Paraneoplastic cerebellar degeneration, metastatic medulloblastoma, intramedullary
spinal cord involvement, etc.· Patients having received prior hormonal therapy for
ovarian cancer including tamoxifen and aromatase inhibitors.· Patients with any other
concurrent disease, which in the opinion of the Investigator, would make the patient
inappropriate for entry into this study.· Patients who are not accessible for
treatment and follow-up in scheduled hours at the participating center.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate toxicities

Principal Investigator

Michael Fung Kee Fung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Canada: Health Canada

Study ID:




Start Date:

January 2003

Completion Date:

September 2007

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial