Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer

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 \</= 10% \& we will pursue further study if the 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.

Timeline

Start

2005-10

Primary completion

2007-02

Completion

2007-02

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual”

Drugs

Indications