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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00132756
• Other study ID #: DO03-25-002
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 18, 2005
• Last updated: November 6, 2006
• Start date: December 2003

Study information

• Verified date: November 2006
• Source: Morton Plant Mease Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Doxil and Estramustine

Locations

Country	Name	City	State
United States	Morton Plant Mease Health Care	Clearwater	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Morton Plant Mease Health Care	Ortho Biotech Products, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the measurable disease and PSA level by at least 50%
Secondary	To determine safety and tolerability