Status:
TERMINATED
Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer
Lead Sponsor:
University of Kentucky
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment. Study Design: We will perf...
Detailed Description
Primary Objectives: To assess the anti-tumor activity of Doxil by assessing response rates in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment. Secondary ...
Eligibility Criteria
Inclusion
- Patients with metastatic hormone refractory prostate cancer as defined by resistance to both ablative therapy (with either LHRH agonists or orchiectomy) \& anti-androgens.
- Patients must have symptoms related to disease.
- Patients must have PS 0,1,2 (ECOG).
- Patients must have measurable disease (RECIST) or PSA \> 5.
- Patients must have adequate organ function as defined as follows: leukocytes \>/= 3,000/mm3, absolute neutrophil count \>/= 1,500/mm3, hemoglobin \>/= 8.0g/dl, platelets \>/= 100,000/mm3, serum creatinine \</= 2.5 mg/dl. Bilirubin must be \</= 2 fold above ULN. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional ULN if alkaline phosphatase is \</= ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are \</= ULN.
- Patients must have a left ventricular ejection fraction (LVEF) 50% by echocardiogram
- Patients must have failed to respond to discontinuation of anti-androgens.
- No previous therapy with anti-androgens, corticosteroids or estrogens in the last 4 weeks.
- Previous radiation therapy is allowed if completed at least 4 weeks prior to study entry \& therapy was cumulatively administered to \</= 25% of bone marrow.
- Patients must be \>18 years of age
- Patients must have an expected survival of at least 4 months.
- Patients must have the ability to understand \& the willingness to sign a written informed consent document.
- Patients must be willing to use adequate contraceptive method during treatment and for 3 months after completing treatment.
Exclusion
- Patients with previous history of cancer are excluded unless they have had curative treatment completed \>/= 5 years prior to entry onto study or had 1 of the following: in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell carcinoma of the skin.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements or the ability to provide informed consent.
- Patients requiring any non study corticosteroids for any reason are excluded.
- Patients who have received previous chemotherapy.
- A history of cardiac disease with New York Heart Class II or greater, or clinical evidence of congestive heart failure.
- Patients may not be receiving any other investigational agents or have participated in any investigational drug study within 4 weeks preceding initiation of treatment.
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery.
- Patients with a lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome or inability to swallow tablets.
- History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil®
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00176293
Start Date
October 1 2005
End Date
February 1 2007
Last Update
April 21 2015
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536