Status:
COMPLETED
Aromasin (Exemestane) in Patients With Recurrent or Refractory Stage II - IV Epithelial Ovarian Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
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 wi...
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 wi...
Eligibility Criteria
Inclusion
- · 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00261027
Start Date
January 1 2003
End Date
September 1 2007
Last Update
March 2 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ottawa Regional Cancer Center
Ottawa, Ontario, Canada, k1h 8l6