Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261027
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2005-11-30
Brief Title:
Aromasin Exemestane in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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 215 patients achieve a response then study will be terminated In 2nd stage if greater than 728 patients achieve a response then no further investigation of the drug is warrantedTreatment 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
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 mgday 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 215 patients achieve a response then study will be terminated In 2nd stage if greater than 728 patients achieve a response then no further investigation of the drug is warrantedTreatment 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
Detailed Description:
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 mgday 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 215 patients achieve a response then study will be terminated In 2nd stage if greater than 728 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
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 mgday 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 215 patients achieve a response then study will be terminated In 2nd stage if greater than 728 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None