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

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
arzoxifene hydrochloride
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ellis Fischel Cancer Center - Columbia
  • Lineberger Comprehensive Cancer Center, UNC
  • Abington Memorial Hospital
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 6, 2012
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00003670
Brief Title
Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer
Official Title
Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
arzoxifene hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej P. Kudelka, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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