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Hormones

arzoxifene hydrochloride

Andrzej P. Kudelka, MD

RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using arzoxifene hydrochloride may fight ovarian or peritoneal 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 metastatic refractory ovarian cancer or primary peritoneal cancer.

OBJECTIVES: I. Evaluate response rate to arzoxifene hydrochloride in patients with metastatic refractory ovarian epithelial cancer or primary peritoneal cancer. II. Determine the time to progressive disease, time to treatment failure, response duration, and survival of these patients. 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).

Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer

Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer

Eli Lilly and Company

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Clifford A. Hudis, MD

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

PURPOSE: This randomized phase II trial is comparing two different doses of arzoxifene hydrochloride to see how well it works in treating women with advanced or metastatic breast cancer.

OBJECTIVES: I. Compare the response rate or clinical benefit rate in patients with locally advanced or metastatic breast cancer treated with 1 of 2 different doses of arzoxifene hydrochloride. II. Compare the response rates and clinical benefit rates for patients with tamoxifen-sensitive versus tamoxifen-refractory disease. III. Compare the degree of toxicity between the 2 doses of arzoxifene hydrochloride in these patients. IV. Compare the quality of life and survival of these patients receiving high versus low dose arzoxifene hydrochloride. V. Determine the time to progressive disease, time to treatment failure, and response duration of this treatment in these patients. VII. Measure changes in serum estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding globulin in these patients during treatment.

OUTLINE: This is a randomized, double blind study. Patients are stratified according to number of metastatic sites (less than 3 vs 3 or more), tamoxifen sensitivity (sensitive vs refractory), and degree of estrogen receptor positivity (high vs low vs unknown). Patients are randomized to receive 1 of 2 doses of arzoxifene hydrochloride. Patients receive arzoxifene hydrochloride orally once daily for 12 weeks. Treatment continues in the absence of toxicity and disease progression. Quality of life is assessed before, during, and at the completion of the study. Patients are followed every 4 weeks for 12 weeks, at 30 days after the last treatment, and every 2-3 months after the last treatment.

PROJECTED ACCRUAL: This study will accrue 104-114 patients.

Hormone Therapy in Treating Women With Breast Cancer

Phase II Randomized Double-Blind Evaluation of Two Dose Levels of LY353381 Hydrochloride Administered to Women With Locally Advanced or Metastatic Breast Cancer

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer	NCT00003670	Ovarian Cancer Primary Periton...	arzoxifene hydr...	18 Years -	Eli Lilly and Company
Hormone Therapy in Treating Women With Breast Cancer	NCT00003428	Breast Cancer	arzoxifene hydr...	18 Years -	Memorial Sloan Kettering Cancer Center
Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer	NCT00003670	Ovarian Cancer Primary Periton...	arzoxifene hydr...	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for arzoxifene hydrochloride