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

NCT00132756 | Terminated Phase 1

• 1 other identifier: DO03-25-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Hormone Refractory; Taxane Refractory

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• To determine safety and tolerability

Interventions

Doxil and Estramustine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Morton Plant Mease Health Care: lead
• Ortho Biotech Products, L.P.: collaborator

Study Sites (1)

Morton Plant Mease Health Care

Clearwater, Florida, 33756, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

liposomal doxorubicin; Estramustine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Robert Drapkin, MD

  Morton Plant Mease Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: December 1, 2003
• Last Updated: November 8, 2006

Record last verified: 2006-11

Locations

US (1)