Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer
- Compare the activity of docetaxel with or without oblimersen, in terms of
prostate-specific antigen response, in patients with hormone-refractory adenocarcinoma
of the prostate.
- Compare the toxicity of these regimens in these patients.
- Compare the time to progression in patients treated with these regimens.
- Compare survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, metastatic disease (M0 vs M1 with non-measurable lesions only vs M1
with measurable lesions), prior estramustine (yes vs no), and prior bisphosphonates (yes vs
no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 5 and oblimersen IV
continuously on days 1-7.
- Arm II: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment
repeats every 21 days for up to 12 courses in the absence of disease progression or
Patients are followed every 8 weeks until progressive disease and then every 16 weeks
PROJECTED ACCRUAL: A total of 102 patients (51 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
Cora N. Sternberg, MD, FACP
Azienda Ospedaliera S. Camillo-Forlanini
United States: Federal Government