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.

Condition	Treatment or Intervention	Phase
recurrent prostate cancer stage IV prostate cancer bone metastases	Drug: celecoxib  Drug: doxorubicin  Drug: strontium chloride Sr 89  Procedure: chemotherapy  Procedure: drug modulation  Procedure: isotope therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

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.

Genders Eligible for Study:  Both

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

Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting

Study chairs or principal investigators

Shi-Ming Tu, MD,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000355360; MDA-ID-02035; NCT00080782
Record last reviewed:  March 2004
Last Updated:  March 10, 2005
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00080782
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08