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Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Doxil and Estramustine
Sponsored by
Morton Plant Mease Health Care
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone Refractory, Taxane Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Morton Plant Mease Health Care

Outcomes

Primary Outcome Measures

Reduce the measurable disease and PSA level by at least 50%

Secondary Outcome Measures

To determine safety and tolerability

Full Information

First Posted
August 18, 2005
Last Updated
November 6, 2006
Sponsor
Morton Plant Mease Health Care
Collaborators
Ortho Biotech Products, L.P.
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1. Study Identification

Unique Protocol Identification Number
NCT00132756
Brief Title
Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
Official Title
Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Morton Plant Mease Health Care
Collaborators
Ortho Biotech Products, L.P.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hormone Refractory, Taxane Refractory

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Doxil and Estramustine
Primary Outcome Measure Information:
Title
Reduce the measurable disease and PSA level by at least 50%
Secondary Outcome Measure Information:
Title
To determine safety and tolerability

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Drapkin, MD
Organizational Affiliation
Morton Plant Mease Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morton Plant Mease Health Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer

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