Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer
Status:
Terminated
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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 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 /= 30%. 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 & severity of toxicities
in both arms.
Treatment:
Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil:
Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone:
Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle.
Number of Cycles for both Arm 1 & 2: until progression or unacceptable toxicity develops.