Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Morton Plant Mease Health Care Ortho Biotech Products, L.P. |
---|---|
Information provided by: | Morton Plant Mease Health Care |
ClinicalTrials.gov Identifier: | NCT00132756 |
The purpose of this research study is to test the safety, tolerability, and effectiveness of the drug combination of Doxil (doxorubicin) and estramustine when used to treat prostate cancer that is resistant to hormones and to a chemotherapy type called taxanes.
The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA) level by at least 50% from baseline.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Doxil and Estramustine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Morton Plant Mease Health Care | |
Clearwater, Florida, United States, 33756 |
Principal Investigator: | Robert Drapkin, MD | Morton Plant Mease Health Care |
Study ID Numbers: | DO03-25-002 |
Study First Received: | August 18, 2005 |
Last Updated: | November 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00132756 |
Health Authority: | United States: Institutional Review Board |
Hormone Refractory Taxane Refractory |
Prostatic Diseases Genital Neoplasms, Male Estramustine Urogenital Neoplasms |
Genital Diseases, Male Taxane Prostatic Neoplasms Doxorubicin |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Antineoplastic Agents, Alkylating Antibiotics, Antineoplastic Alkylating Agents Pharmacologic Actions |