Metastatic Cancer, Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage IV prostate cancer, bone metastases, Progressive Androgen-Independent Prostate Cancer, Metastron, Sr-89, Strontium-89, strontium chloride Sr 89, Celecoxib, Celebrex, Doxorubicin, Rubex, Adriamycin
Brief summary
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.
Detailed description
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.
Interventions
DRUGCelecoxib
Oral celecoxib twice daily in the absence of disease progression.
DRUGDoxorubicin Hydrochloride
By vein (IV) over 30 minutes on days 1, 8, 15, and 22
RADIATIONStrontium chloride Sr 89
IV on day 1
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of androgen-independent prostate cancer * Osteoblastic metastases * No predominant visceral metastases * Progressive disease after response to prior induction chemotherapy (prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment) * No symptomatic lymphadenopathy (i.e., scrotal or pedal edema) PATIENT CHARACTERISTICS: Age * Any age Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Adequate physiologic reserves PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * No prior radionuclide therapy Surgery * Not specified Other * No more than 3 prior cytotoxic treatments * More than 6 months since prior celecoxib or rofecoxib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to prostate-specific antigen progression | Continuous assessment 16 weeks of treatment |
Countries
United States
Outcome results
None listed