Expired Study
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Minneapolis, Minnesota 55455


Purpose:

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 summary:

OBJECTIVES: Primary - 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. Secondary - 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.


Criteria:

Inclusion Criteria: - Histologically confirmed ovarian epithelial carcinoma - Recurrent or persistent disease - Must have received greater than or equal to (≥) 2 prior cytotoxic chemotherapy regimens, including ≥ 1 platinum-containing regimen - Disease not amenable to curative treatment with surgery and/or radiotherapy - Must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or a serum cancer antigen 125 (CA-125) level that is rising and meets 1 of the following criteria: - Serum CA-125 level greater than (>) upper limit of normal (typically 35 μ/mL) on two evaluations at least 2 weeks apart - Serum CA-125 level less than (<) 35 μ/mL but has risen progressively > 200% over successive specimens ≥ 2 weeks apart - Estrogen receptor-positive tumor - Gynecologic Oncology Group (GOG) performance status 0-3 - Platelet count ≥ 50 x 10^9/Liter - Serum creatinine less than or equal to (≤) 2.5 mg/deciliter - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times upper limit of normal (ULN) - alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases) - Alkaline phosphatase ≤ 3 times ULN - Prothrombin time-International Normalized Ratio (INR) ≤ 1.6 - Not pregnant or nursing - Negative pregnancy test - Must be sterile or fertile patients must use effective contraception (i.e., double method including ≥ 1 barrier, injectable, implantable, condoms plus spermicide) - Prior malignancy allowed provided the patient has been disease-free for ≥ 5 years - Patients with previously diagnosed basal cell skin cancer are eligible immediately after completing therapy - No history of bleeding (i.e., disseminated intravascular coagulation or clotting factor deficiency) - No documented sensitivity to active or inactive excipients of fulvestrant (i.e., castor oil or mannitol) - Recovered from the effects of prior surgery, radiotherapy, and/or chemoradiotherapy - At least 3 weeks since prior chemotherapy - At least 3 weeks since prior complete radiotherapy regimen alone or chemoradiotherapy - An incomplete radiotherapy regimen (< 500 Gray) is allowed within the 3-week time frame Exclusion Criteria: - Concurrent hormone replacement therapy - Prior long-term anticoagulation therapy other than anti-platelet therapy


NCT ID:

NCT00617188


Primary Contact:

Principal Investigator
Peter A. Argenta, MD
Masonic Cancer Center, University of Minnesota


Backup Contact:

N/A


Location Contact:

Minneapolis, Minnesota 55455
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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