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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003670 |
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.
Condition | Intervention | Phase |
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Ovarian Cancer Peritoneal Cavity Cancer |
Drug: arzoxifene hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer |
Study Start Date: | October 1998 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic refractory ovarian epithelial cancer OR primary peritoneal cancer provided the clinical and pathological features of the tumor are similar to primary ovarian epithelial carcinoma Patients must have received prior chemotherapy including at least one platinum analogue and one taxane analogue unless patient is poor candidate for these treatments due to neuropathy, nephropathy, or hypersensitivity (to Taxol only) Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam Ascites not considered measurable or evaluable Hormone receptor status: Estrogen receptor status must be known or tissue must be available for analysis
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Sex: Female Menopausal status:
Not specified Life expectancy: At least 24 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 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: See Disease Characteristics No more than 2 prior chemotherapy regimens (including repeated drug combinations) for patients with potentially platinum-sensitive disease No more than 3 prior chemotherapy regimens (including repeated drug combinations) for patients with platinum resistant disease At least 6 weeks since mitomycin or nitrosoureas At least 3 weeks since other prior chemotherapy Recovered from prior chemotherapy Endocrine therapy: At least 3 weeks since hormone replacement therapy No prior hormonal therapy for ovarian cancer Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: Not specified
United States, Missouri | |
Ellis Fischel Cancer Center - Columbia | |
Columbia, Missouri, United States, 65203 | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center, UNC | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
United States, Pennsylvania | |
Abington Memorial Hospital | |
Abington, Pennsylvania, United States, 19001 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Andrzej P. Kudelka, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000066767, LILLY-H4Z-MC-JWWJ, MDA-DM-98225 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003670 History of Changes |
Health Authority: | United States: Federal Government |
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Hormones |
Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms |
Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |