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Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT00004915
Recruitment Status : Completed
First Posted : August 30, 2004
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

March 7, 2000
August 30, 2004
June 6, 2012
November 1998
February 2000   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004915 on ClinicalTrials.gov Archive Site
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Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer
Phase II Study of Raloxifene in Recurrent Endometrial Cancer

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.

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.

Phase 2
Primary Purpose: Treatment
Endometrial Cancer
Drug: raloxifene
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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February 2000
February 2000   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NU 98G1
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Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Phillip Y. Roland, MD Florida Gynecologic Oncology - Fort Myers
Northwestern University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP