Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003669
• Other study ID #: 2141
• Secondary ID: LILLY-H4Z-MC-JWW
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 6, 2012
• Start date: November 1998
• Est. completion date: April 2001

Study information

• Verified date: April 2008
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using arzoxifene hydrochloride may fight the endometrial cancer by blocking the use of estrogen by the tumor cells

PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating women with recurrent, advanced, or metastatic endometrial cancer.

Description:

OBJECTIVES: I. Determine the objective tumor response rate (complete response and partial response) to arzoxifene hydrochloride in patients with recurrent or advanced endometrial cancer. II. Determine the time to progressive disease, time to treatment failure, response duration, and survival in patients with recurrent or advanced endometrial cancer receiving arzoxifene hydrochloride. III. Assess the safety of this treatment in these patients. IV. Measure changes in serum estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding globulin during this treatment in these patients.

OUTLINE: Patients receive oral arzoxifene hydrochloride daily at a fixed dose. Treatment continues in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: Not specified

National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record when the trial completed. In June 2012, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial completion date. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed recurrent, advanced, or metastatic endometrial cancer not amenable to curative surgery or radiotherapy Patients should have previously undergone radical surgery (minimum of total abdominal hysterectomy and bisalpingoophorectomy), radical radiotherapy, or not be candidate for such procedures Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam No papillary serous or clear cell carcinomas of the endometrium Hormone receptor status: Estrogen receptor positive and/or progesterone receptor positive Unknown receptor status patients allowed provided (1) original tumor was well- or moderately-well differentiated (2) had endometrioid histology

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Menopausal status: Not specified Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion-independent) Prothrombin time or activated partial thromboplastin time no greater than 1.25 times upper limit of normal (ULN) Hepatic: Bilirubin no greater than 1.5 times normal ALT or AST no greater than 2.5 times ULN (ALT and AST no greater than 5 times ULN in the presence of liver metastases) Renal: Creatinine no greater than 1.5 ULN Other: No other primary malignancy within the past 5 years except adequately treated nonmelanomatous cancer of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for recurrent or metastatic endometrial cancer At least 1 year since prior adjuvant chemotherapy Endocrine therapy: No prior antiestrogen therapy for any stage of endometrial cancer At least 12 months from time of diagnosis since prior raloxifene Prior progesterone treatment allowed Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• arzoxifene hydrochloride

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Grant/Riverside Methodist Hospitals	Columbus	Ohio
United States	U.S. Oncology	Houston	Texas
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Huntington Memorial Hospital	Pasadena	California
United States	Washington University Barnard Cancer Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,