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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| response rate toxicities |
| Measure | Description | Time Frame |
|---|---|---|
| -Time to detectable virus in the Alvac alone group and the placebo group. -Time to rebound of plasma HIV RNA level to 10,000 copies/ml -Viral set-point -Magnitude of viral rebound -HIV-specific immune function at week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fung Kee Fung, MD | OHRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Regional Cancer Center | Ottawa | Ontario | k1h 8l6 | Canada |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |