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Liposomal Doxorubicin and Estramustine Phosphate: Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
This study has been terminated.
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
  Purpose

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

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Estramustine Estramustine phosphate Estramustine phosphate sodium
U.S. FDA Resources
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

Further study details as provided by Morton Plant Mease Health Care:

Primary Outcome Measures:
  • Reduce the measurable disease and PSA level by at least 50%

Secondary Outcome Measures:
  • To determine safety and tolerability

Estimated Enrollment: 30
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00132756

Locations
United States, Florida
Morton Plant Mease Health Care
Clearwater, Florida, United States, 33756
Sponsors and Collaborators
Morton Plant Mease Health Care
Ortho Biotech Products, L.P.
Investigators
Principal Investigator: Robert Drapkin, MD Morton Plant Mease Health Care
  More Information

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

Keywords provided by Morton Plant Mease Health Care:
Hormone Refractory
Taxane Refractory

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Estramustine
Urogenital Neoplasms
Genital Diseases, Male
Taxane
Prostatic Neoplasms
Doxorubicin

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009