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Sponsored by: |
George Washington University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003865 |
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.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer |
Drug: toremifene |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary |
Study Start Date: | July 1999 |
OBJECTIVES:
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: A total of 60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed serous papillary carcinoma of the ovary
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, District of Columbia | |
George Washington University Cancer Center | |
Washington, District of Columbia, United States, 20037 |
Study Chair: | James D. Ahlgren, MD | George Washington University |
Study ID Numbers: | CDR0000067029, GWCC-7096, NCI-V99-1540 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003865 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer ovarian serous cystadenocarcinoma |
Cystadenocarcinoma, Serous Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian epithelial cancer Toremifene Recurrence Carcinoma Genital Diseases, Female Carcinoma, Papillary Endocrinopathy Endocrine Gland Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Selective Estrogen Receptor Modulators |
Pharmacologic Actions Adnexal Diseases Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |