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Phase II Study of Raloxifene in Recurrent Endometrial Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

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Trial Information

Phase II Study of Raloxifene in 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Phillip Y. Roland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Florida Gynecologic Oncology - Fort Myers

Authority:

United States: Federal Government

Study ID:

NU 98G1

NCT ID:

NCT00004915

Start Date:

November 1998

Completion Date:

February 2000

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611