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Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer


OBJECTIVES: I. Determine the objective tumor response rate (complete response and partial
response) to arzoxifene hydrochloride in patients with recurrent or advanced endometrial
cancer. II. Determine the time to progressive disease, time to treatment failure, response
duration, and survival in patients with recurrent or advanced endometrial cancer receiving
arzoxifene hydrochloride. 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).

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

2141

NCT ID:

NCT00003669

Start Date:

November 1998

Completion Date:

April 2001

Related Keywords:

  • Endometrial Cancer
  • stage IV endometrial carcinoma
  • recurrent endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Abington Memorial HospitalAbington, Pennsylvania  19001
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
Grant/Riverside Methodist HospitalsColumbus, Ohio  43214
U.S. OncologyHouston, Texas  77060
Huntington Memorial HospitalPasadena, California  91109-7013