Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Roswell Park Cancer Institute |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00244998 |
RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.
PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with advanced prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: fulvestrant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Fulvestrant (Faslodex®) in Androgen Independent Prostate Cancer |
Estimated Enrollment: | 33 |
Study Start Date: | September 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study.
Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Courses repeat once a month in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Must have androgen-independent prostate cancer meeting the following criteria:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Bilirubin normal
Renal
Cardiovascular
No new onset crescendo or rest angina
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Principal Investigator: | Donald L. Trump, MD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000447133, RPCI-I-53805 |
Study First Received: | October 25, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00244998 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage III prostate cancer stage IV prostate cancer |
Estrogens Estrogen Antagonists Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant |
Urogenital Neoplasms Genital Diseases, Male Hormones Estrogen Receptor Modulators Adenocarcinoma Prostatic Neoplasms Androgens |
Estrogen Antagonists Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant |
Urogenital Neoplasms Genital Diseases, Male Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |