Prostate Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop
tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain
caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to
the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin
and strontium-89 with celecoxib may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and
strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in
treating patients with progressive androgen-independent prostate cancer and bone metastases.
OBJECTIVES:
- 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.
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