Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
NCT ID: NCT00132756
Last Updated: 2006-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2003-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary hypothesis is to reduce the measurable disease or prostate-specific antigen (PSA) level by at least 50% from baseline.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Doxil and Estramustine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must have evaluable disease that may be evaluated by PSA or measurement.
* Patients must be hormone refractory as defined in this protocol.
* Patients must be taxane refractory as defined in this protocol.
* Patients have had no prior chemotherapy other than a taxane or estramustine phosphate.
* Patients may have had prior radiation therapy (RT) if it has been \>/= 4 weeks since completion.
* Patients on bisphosphonates may be included.
* Patients must be at least 18 years of age or older.
* Patients must have the ability to speak and understand English.
* Patients must have an ECOG performance status of 2 or less.
* Patients must have adequate bone marrow function: platelets \> 100,000 cells/mm3; hemoglobin \> 9.0 g/dL; and absolute neutrophil count (ANC) \> 1,000 cells/mm3.
* Patients must have adequate renal function: creatinine \< 2.5 mg/dL.
* Patients must have adequate liver function.
* Ejection fraction of \> 50% within 42 days of first dose of study drug.
* Ability to complete the McGill-Melzack Pain Intensity Scale.
Exclusion Criteria
* History of hypersensitivity to doxorubicin.
* History of class II cardiac disease or evidence of congestive heart failure.
* RT within the past 4 weeks of study entry or a radiopharmaceutical within the past 8 weeks of study entry.
* Prior malignancy within the past 5 years except for non-melanotic skin cancers.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ortho Biotech Products, L.P.
INDUSTRY
Morton Plant Mease Health Care
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Drapkin, MD
Role: PRINCIPAL_INVESTIGATOR
Morton Plant Mease Health Care
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Morton Plant Mease Health Care
Clearwater, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DO03-25-002
Identifier Type: -
Identifier Source: org_study_id