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| Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004915 |
Purpose
RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using raloxifene may fight endometrial cancer by reducing the production of estrogen.
PURPOSE: Phase II trial to study the effectiveness of raloxifene in treating patients who have persistent or recurrent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: raloxifene |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Raloxifene in Recurrent Endometrial Cancer |
| Study Start Date: | January 2000 |
OBJECTIVES: I. Determine response rate and time to disease progression in patients with recurrent endometrial cancer treated with raloxifene. II.
Determine overall survival in these patients treated with this regimen. III. Determine the toxicity of raloxifene in this patient population.
OUTLINE: Patients receive oral raloxifene daily. Treatment continues indefinitely in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 13-50 patients will be accrued for this study within 2.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Recurrent endometrial cancer Evidence of persistent or recurrent disease 4 weeks following primary treatment with radiation and surgery Bidimensionally measurable disease Not a candidate for curative salvage radiotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No history of unexplained or uncontrolled thromboembolic disease No active thromboembolic disease Other: No active or uncontrolled second malignancy HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy for early stage or advanced endometrial cancer Endocrine therapy: At least 4 weeks since prior hormonal therapy for early stage or advanced endometrial cancer Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Phillip Y. Roland, MD | Florida Gynecologic Oncology - Fort Myers |
More Information
| Study ID Numbers: | CDR0000067595, NU-98G1, NCI-G00-1710 |
| Study First Received: | March 7, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004915 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma |
|
Estrogen Antagonists Estrogens Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Genital Neoplasms, Female Uterine Diseases Bone Density Conservation Agents Urogenital Neoplasms Endometrial Cancer |
Selective Estrogen Receptor Modulators Hormones Recurrence Carcinoma Genital Diseases, Female Estrogen Receptor Modulators Endometrial Neoplasms Raloxifene Uterine Neoplasms |
|
Estrogen Antagonists Hormone Antagonists Physiological Effects of Drugs Genital Neoplasms, Female Hormones, Hormone Substitutes, and Hormone Antagonists Uterine Diseases Bone Density Conservation Agents Urogenital Neoplasms Selective Estrogen Receptor Modulators |
Pharmacologic Actions Genital Diseases, Female Estrogen Receptor Modulators Endometrial Neoplasms Neoplasms Raloxifene Neoplasms by Site Uterine Neoplasms |
