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

Sponsor
Morton Plant Mease Health Care (Other)
Overall Status
Terminated
CT.gov ID
NCT00132756
Collaborator
Ortho Biotech Products, L.P. (Industry)
30
Enrollment
1
Location

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Doxil and Estramustine
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Liposomal Doxorubicin and Estramustine Phosphate: A Phase II Study in Taxane Resistant, Hormone Refractory Advanced Prostate Cancer
Study Start Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Reduce the measurable disease and PSA level by at least 50% []

Secondary Outcome Measures

  1. To determine safety and tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00132756
Other Study ID Numbers:
  • DO03-25-002
First Posted:
Aug 22, 2005
Last Update Posted:
Nov 8, 2006
Last Verified:
Nov 1, 2006
Keywords provided by , ,
Hormone Refractory
Taxane Refractory
Additional relevant MeSH terms:
Prostatic Neoplasms
Estramustine

Study Results

No Results Posted as of Nov 8, 2006