Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor cells.
PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent ovarian epithelial cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma|
- Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]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.
- Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]Defined by the sum of Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=normalization of serum CA-125 level from 2 initially elevated samples, PR=>or=50% decrease in serum CA-125 level from 2 initially elevated samples, Progressive Disease (PD)=CA-125 two times the upper limit of normal on 2 occasions (if previously normalized) OR CA-125 two times nadir (lowest value) on 2 occasions if elevated at initiation of treatment, SD=not CR, PR or PD.
- Median Number of Days to Treatment Termination [ Time Frame: Up to 373 Days ] [ Designated as safety issue: No ]Time is determined from first dose to termination due to all causes.
- Mean Scores - Quality of Life Assessment [ Time Frame: Baseline, 3 Months Post Treatment, 6 Months Post Treatment ] [ Designated as safety issue: No ]Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O)Version 1/23/07 - This is a relative quality of life assessment; 100 = Best, 0 = Worst. It was developed and validated with cancer patients and includes physical well being, social well being, emotional well being and relationship with doctor subscales and can be summed into one total quality of life score. It is a standardized scale which collects data (scores 1-4) from 47 questions. Answers are transformed into a number between 0-100. Mean was calculated by adding up the values of the scores and dividing by the number of scores.
- Serum Skeletal-Specific Alkaline Phosphatase Concentration [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months ] [ Designated as safety issue: No ]Median Bone mineral results - assessed by serum skeletal-specific alkaline phosphatase laboratory results collected from patients in study.
- Urine N-telopeptide Concentration [ Time Frame: Baseline, 1 Month, 3 Months, 6 Months ] [ Designated as safety issue: No ]Median bone mineral results - assessed by serial urine N-telopeptide laboratory results collected from patients.
|Study Start Date:||June 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.
Other Name: Faslodex
- 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 questionnaire.
After completion of study treatment, patients are followed at approximately 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617188
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Peter A. Argenta, MD||Masonic Cancer Center, University of Minnesota|