- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132756
Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
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.
Study Overview
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Clearwater, Florida, United States, 33756
- Morton Plant Mease Health Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically confirmed advanced, prostate cancer
- 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:
- Patients with unstable medical conditions such as liver, renal dysfunctions, blood clots or heart disease.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Reduce the measurable disease and PSA level by at least 50%
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Secondary Outcome Measures
Outcome Measure |
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To determine safety and tolerability
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Drapkin, MD, Morton Plant Mease Health Care
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DO03-25-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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