Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Cancer
Intervention: raloxifene (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Robert H. Lurie Cancer Center Official(s) and/or principal investigator(s):
Phillip Y. Roland, MD, Study Chair, Affiliation: Florida Gynecologic Oncology - Fort Myers
Summary
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.
Clinical Details
Official title: Phase II Study of Raloxifene in Recurrent Endometrial Cancer
Study design: Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: January 2000
Last updated: May 23, 2008
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