Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma
- To determine the 90-day clinical benefit (defined as the sum of complete responses,
partial responses, and stable disease) in patients with recurrent ovarian epithelial
cancer treated with single agent fulvestrant.
- To establish the time to termination of treatment (due to all causes including
progression and intolerance) for patients treated with this drug.
- To describe the toxicities observed in patients treated with this drug.
- To evaluate the quality of life of patients treated with this drug.
- To determine the effect that prolonged estrogen receptor antagonism has on markers of
bone mineral turnover.
OUTLINE: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then
on day 1 of all subsequent courses. Treatment repeats every 28 days for up to 1 year in the
absence of disease progression or unacceptable toxicity. Patients in continued response at
the end of 1 year may continue treatment at the discretion of the treating physician.
Urinary N-telopeptide and serum skeletal-specific alkaline phosphatase are assessed at
baseline and at 1, 3, and 6 months during study to determine the influence of estrogen
blockade on bone mineral turnover.
Quality of life is assessed at baseline and every 3 months during treatment, and at the end
of treatment using The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) cancer
After completion of study treatment, patients are followed at approximately 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.
Peter A. Argenta, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|