Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer
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| Tracking Information | |||||
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| First Received Date ICMJE | March 7, 2000 | ||||
| Last Updated Date | May 31, 2012 | ||||
| Start Date ICMJE | November 1998 | ||||
| Primary Completion Date | February 2000 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00004915 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer | ||||
| Official Title ICMJE | Phase II Study of Raloxifene in Recurrent Endometrial Cancer | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Endometrial Cancer | ||||
| Intervention ICMJE | Drug: raloxifene | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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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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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | February 2000 | ||||
| Primary Completion Date | February 2000 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00004915 | ||||
| Other Study ID Numbers ICMJE | NU 98G1, NU-98G1, NCI-G00-1710 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Northwestern University | ||||
| Study Sponsor ICMJE | Northwestern University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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