Expired Study
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Washington, D.C., District of Columbia 20037


Purpose:

RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen. PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer.


Study summary:

OBJECTIVES: - Determine the effects of toremifene in terms of response rate, duration of response, duration of survival, and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary. - Assess whether a dose response effect is likely for this regimen in these patients. - Assess quality of life of these patients. OUTLINE: This is a randomized study. Patients receive one of two doses of oral toremifene daily for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before therapy and then every 4 weeks during therapy. Patients are followed every 12 weeks until death. PROJECTED ACCRUAL: The study was closed before any patient accrual.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed serous papillary carcinoma of the ovary - Recurrent or refractory disease following at least one regimen including paclitaxel, cisplatin, or carboplatin - Measurable disease outside of irradiated field - No CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - At least 16 weeks Hematopoietic: - Absolute neutrophil count at least 1,800/mm^3 - Platelet count at least 125,000/mm^3 - No history of thrombosis or thromboembolic events Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study - No other concurrent second malignancy or prior malignancy within past 5 years, except basal or squamous cell skin cancer or curatively treated stage I carcinoma of the cervix - No concurrent infection - At least 3 days since prior fever (unless due to tumor) - No other concurrent severe medical illness - No HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No concurrent chemotherapy Endocrine therapy: - No prior tamoxifen or antiestrogen therapy Radiotherapy: - See Disease Characteristics - At least 6 months since prior radiotherapy - No concurrent radiotherapy except to symptomatic or potentially disabling bone lesion accompanied by other measurable disease Surgery: - Not specified Other: - No concurrent anticoagulants - No other concurrent therapeutic trials


NCT ID:

NCT00003865


Primary Contact:

Study Chair
James D. Ahlgren, MD
George Washington University


Backup Contact:

N/A


Location Contact:

Washington, D.C., District of Columbia 20037
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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