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| Sponsor: | George Washington University |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003865 |
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.
| 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000067029, GWCC-7096, NCI-V99-1540 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003865 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer ovarian serous cystadenocarcinoma |
|
Ovarian Neoplasms Antineoplastic Agents, Hormonal Antineoplastic Agents Gonadal Disorders Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Genital Neoplasms, Female Endocrine System Diseases Bone Density Conservation Agents Urogenital Neoplasms |
Ovarian Diseases Selective Estrogen Receptor Modulators Toremifene Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Endocrine Gland Neoplasms |