A Randomized Phase II Trial of Doxil With or Without Dexamethasone in Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer
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.
To assess and estimate in patients with hormone refractory prostate cancer treated with
Doxil with or without pre-treatment dexamethasone: 1) overall survival 2) toxicity, 3)
quality of life parameters, 4) dose intensity administered in both treatment groups.
We will perform an open labeled, parallel, randomized phase II study using a two-stage
design to determine if there is sufficient anti-tumor activity in either arm to warrant
further study. Assumptions made in this study: an unacceptable overall response rate is =
10% and we will pursue further study if the overall response rate is >/= 30%. The overall
response rate for this study will be based on the total number of responses observed defined
as: complete responses + partial responses (both by RECIST)+biochemical responses (in
patients with no measurable target lesions a >/= 50% decrease in PSA for >/= 4 weeks).
Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further
patients will be accrued if <2/15 responses are noted in a given arm. Ten additional
patients will be enrolled if >/= 2/15 responses are observed. If there are >/= 5/25
responses then further studies will be pursued with that regimen. We will determine the
overall incidence and severity of toxicities in both arms.
Arm 1: Doxil: Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 2: Doxil:
Dose: 50 mg/m2, IV. Frequency: day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose:
12 mg bid po. Frequency: days 1,2,3,4,5 of each 28 day cycle.
Number of Cycles for both Arm 1 and 2: until progression or unacceptable toxicity develops.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of subjects with CR or PR
evaluated after 2 courses then every other course
John Rinehart, MD
University of Kentucky
United States: Food and Drug Administration
|University of Kentucky||Lexington, Kentucky 40536-0098|