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

November 6, 2006 updated by: Morton Plant Mease Health Care

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

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Clearwater, Florida, United States, 33756
        • Morton Plant Mease Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Secondary Outcome Measures

Outcome Measure
To determine safety and tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morton Plant Mease Health Care

Collaborators

Ortho Biotech Products, L.P.

Investigators

  • Principal Investigator: Robert Drapkin, MD, Morton Plant Mease Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

November 8, 2006

Last Update Submitted That Met QC Criteria

November 6, 2006

Last Verified

November 1, 2006

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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