Fulvestrant in Hormone Refractory Prostate Cancer - Full Text View

Sponsor:	Stanford University
Collaborator:	AstraZeneca
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00476645

Purpose

The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA).

Condition	Intervention	Phase
Prostatic Neoplasms Prostate Cancer Prostate Cancer Localized Disease Prostate Cancer Metastatic Disease	Drug: Fulvestrant	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Fulvestrant in Hormone Refractory Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Ici 182780

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Efficacy, defined as the first evidence of a total serum PSA decline of >50% from baseline maintained for at least 28 days and confirmed with two consecutive measurements taken two weeks apart [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to progression, defined as the time from first administration of study drug to the first observation of disease progression [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
Disease progression, defined as an increase of >25% over the baseline PSA on two consecutive measurements two weeks apart, need for palliative therapy, or a decline in at least 20% in KPS [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
Time to sustained biochemical response, defined as the time from first administration of drug to first evidence of sustained response [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]
Duration of sustained response, defined as time from PSA decrease of >50% from baseline to the first evidence of disease progression [ Time Frame: at 3months and monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2006
Study Completion Date:	December 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Detailed Description:

The purpose of this study is to determine if treatment with fulvestrant leads to a slowing of tumor progression in patients who have developed androgen-independent (AIPC) or hormone-refractory prostate cancer (HRPC) and who have a rising serum prostate specific antigen (PSA). In vitro studies have shown that fulvestrant downregulates androgen receptor (AR) in LNCaP cancer cell lines to a significant extent, thereby inhibiting growth of tumor cells. In addition, it is important to emphasize that fulvestrant has also been found to decrease growth of AR-negative prostate cancer cells. These observations provide the rational for using fulvestrant for the treatment of AIPC and HRPC.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:1. Must give signed written informed consent 2. Must be of age 18 years or older 3. Histologically confirmed adenocarcinoma of the prostate 4. Must be currently receiving LHRH agonists and have castrate levels of testosterone or have had an orchiectomy 5. Must have had rise in PSA despite anti-androgen withdrawal 6. Must exhibit two consecutive rises in PSA after the last hormonal manipulation 7. Minimum PSA > 5mg/dL 8. KPS > 80% 9. Up to one prior chemotherapy treatments allowed 10.Life expectancy of greater than 6 months

Exclusion Criteria:1. Concomitant hormonal therapy other than an LHRH 2. Noncompliance 3. Platelets less than 100 x 10^9 /L 4. International normalization ratio (INR) greater than 1.6 5. Total bilirubin greater than 1.5 x ULRR 6. ALT or AST greater than 2.5 x ULRR if no demonstrable liver metastases or greater than 5.0 x ULRR in presence of liver metastases 7. History of:

bleeding diathesis (ie, disseminated intravascular coagulation [DIC], clotting factor deficiency) or
long-term anticoagulant therapy (other than antiplatelet therapy).
hypersensitivity to active or inactive excipients of fulvestrant (ie castor oil or Mannitol)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476645

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

AstraZeneca

Investigators

Principal Investigator:

Dr. Sandy Srinivas

Stanford University

More Information

No publications provided

Responsible Party:	Dr. Sandy Srinivas, Stanford University School of Medicine
ClinicalTrials.gov Identifier:	NCT00476645 History of Changes
Other Study ID Numbers:	PROS0010, 96025, PROS0010
Study First Received:	May 18, 2007
Last Updated:	July 23, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Neoplasm Metastasis
Prostatic Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

Hormones
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 09, 2012