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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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 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).

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Andrzej P. Kudelka, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

October 1998

Completion Date:

January 2001

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Abington Memorial Hospital Abington, Pennsylvania  19001
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203