Phase I Study Evaluating Extended Field Intensity Modulated Radiation Therapy and Docetaxel in Patients With Prostate Cancer Associated With Pelvic Node Metastasis
- Determine, preliminarily, the grade III or IV toxicity rate of concurrent
extended-field intensity-modulated radiotherapy (IMRT), docetaxel, and androgen
deprivation therapy in patients with high-risk, locally advanced prostate cancer with
pelvic lymph node metastasis.
- Determine, preliminarily, the progression-free survival of patients treated with this
- Determine the maximum tolerated dose of docetaxel when administered with concurrent
IMRT in this patients.
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive combined androgen deprivation therapy (if not already on combined hormonal
therapy) comprising goserelin acetate* subcutaneously once every 3 months for up to 2 years
and oral bicalutamide once daily beginning on day 1 and continuing until the completion of
radiotherapy. Beginning at approximately week 9 of androgen deprivation therapy, patients
receive docetaxel IV over 1 hour once weekly for up to 9 weeks. Concurrently with
chemotherapy, patients undergo intensity-modulated radiotherapy 5 days a week for up to 45
fractions (9 weeks).
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.
NOTE: *Not required for patients who have undergone bilateral orchiectomy
After completion of study therapy, patients are followed periodically for 5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity rate as assessed by NCI CTCAE v3.0
during therapy and follow-up visits to continue for 5 years after radiation is completed
Ralph Hauke, MD
University of Nebraska
United States: Institutional Review Board
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|