A Phase I/II Study of Concurrent Weekly Docetaxel (Taxotere®), Androgen Ablation, and Adaptive External Beam Radiotherapy for Localized High-Risk Adenocarcinoma of the Prostate
- Determine the dose-limiting toxicity and maximum tolerated dose of docetaxel when
administered in combination with androgen ablation therapy and adaptive external-beam
radiotherapy in patients with high-risk localized adenocarcinoma of the prostate.
- Determine the 2-year biochemical progression-free survival of patients treated with
OUTLINE: This is a multicenter, open-label, dose-escalation study of docetaxel.
- Androgen ablation therapy: Patients receive leuprolide acetate or other luteinizing
hormone-releasing hormone agonist beginning 2-3 months prior to the start of
chemoradiotherapy and continuing for up to 2 years.
- Chemoradiotherapy: Patients receive docetaxel IV over 1 hour on day 1 and high-dose
external-beam radiotherapy on days 1-5. Treatment repeats every 7 days for 8 courses in
the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed every 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA progression timepoint is defined as the midpoint between the last non-rising PSA and the first rising PSA.
when 3 consecutive rising PSA values have been noted
Young Whang, MD, PhD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Rex Cancer Center at Rex Hospital||Raleigh, North Carolina 27607|