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

NCT00003669 | Completed Phase 2

• 4 other identifiers: 2141LILLY-H4Z-MC-JWWIMSKCC-99001CDR0000066766
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Endometrial Cancer

Keywords

stage IV endometrial carcinoma; recurrent endometrial carcinoma

Interventions

arzoxifene hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (10)

Huntington Memorial Hospital

Pasadena, California, 91109-7013, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Grant/Riverside Methodist Hospitals

Columbus, Ohio, 43214, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

U.S. Oncology

Houston, Texas, 77060, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Paul Sabbatini, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 25, 2004
• Study Start: November 1, 1998
• Study Completion: April 1, 2001
• Last Updated: June 7, 2012

Record last verified: 2008-04

Locations

US (10)