A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer
- Compare time to prostate-specific antigen progression in patients with progressive
androgen-independent prostate cancer and bone metastases treated with doxorubicin and
strontium chloride Sr 89 with or without celecoxib.
OUTLINE: This is a randomized study. Patients are stratified according to extent of bone
metastases on bone scan (> 20 lesions vs ≤ 20 lesions) and quality of response (i.e.,
decline of the prostate-specific antigen from baseline) to prior induction chemotherapy (≥
80% vs < 80%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 and
strontium chloride Sr 89 IV on day 1. Patients also receive oral celecoxib twice daily
in the absence of disease progression.
- Arm II: Patients receive doxorubicin and strontium chloride Sr 89 as in arm I.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this
study within 18 months.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to prostate-specific antigen progression
Continuous assessment 16 weeks of treatment
Shi-Ming Tu, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|