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Phase II Study of Raloxifene in Patients With Recurrent Endometrial Cancer (Summary Last Modified 08/2000)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Completed

18 and over

NCI

NU-98G1
NCI-G00-1710, NCT00004915

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.

Entry 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

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

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

Expected Enrollment

A total of 13-50 patients will be accrued for this study within 2.5 years.

Outline

Patients receive oral raloxifene daily.  Treatment continues indefinitely in 
the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Phillip Roland, MD, Protocol chair
Ph: 239-334-6626

Registry Information

Official Title		Phase II Study of Raloxifene in Recurrent Endometrial Cancer

Trial Start Date		2000-01-05

Registered in ClinicalTrials.gov		NCT00004915

Date Submitted to PDQ		2000-01-13

Information Last Verified		2000-08-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.