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Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer Clinical research trials and Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer. Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer  Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
For Condition: recurrent endometrial cancer,stage 4 endometrial cancer
Status: No longer recruiting
Sponsor(s): Eli Lilly and Company ,
Synopsis: RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using LY353381 hydrochloride may fight the endometrial cancer by blocking the uptake of estrogen by the cancer cells. PURPOSE: Phase II trial to study the effectiveness of LY353381 hydrochloride in treating women who have recurrent, advanced, or metastatic endometrial cancer.
Details: OBJECTIVES: I. Determine the objective tumor response rate (complete response and partial response) to LY353381 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 LY353381 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. PROTOCOL OUTLINE: Patients receive oral LY353381 hydrochloride daily at a fixed dose. Treatment continues in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: Not specified
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulSabbatini, Study Chair, Eli Lilly and Company
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Grant/Riverside Methodist Hospitals
Columbus, Ohio, 43214
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Washington University Barnard Cancer Center
St. Louis, Missouri, 63110
United States
Huntington Memorial Hospital
Pasadena, California, 91109-7013
United States
U.S. Oncology
Houston, Texas, 77060
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066766; LILLY-H4Z-MC-JWWI,MSKCC-99001
Study Start Date: November 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003669
Other Stage 4 Endometrial Cancer Studies:
1. Liposomal Doxorubicin in Treating Patients with Advanced or Recurrent Endometrial Cancer
2. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
3. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
4. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
5. Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
Related Studies:
Other stage 4 endometrial cancer Clinical Trials
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Other Oklahoma City Clinical Trials
Hormone Therapy With LY353381 Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
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