Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer

Conditions
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Metastatic Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Doxorubicin Hydrochloride
* Radiation: Strontium chloride Sr 89


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I: Celecoxib<br>Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1, and oral celecoxib twice daily in absence of disease progression. | Drug: Celecoxib<br>* Oral celecoxib twice daily in the absence of disease progression.<br>* Other names: Celebrex;Drug: Doxorubicin Hydrochloride<br>* By vein (IV) over 30 minutes on days 1, 8, 15, and 22<br>* Other names: Rubex;Radiation: Strontium chloride Sr 89<br>* IV on day 1<br>* Other names: Strontium-89;|
| Experimental: Arm II: No Celecoxib<br>Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1. | Drug: Doxorubicin Hydrochloride<br>* By vein (IV) over 30 minutes on days 1, 8, 15, and 22<br>* Other names: Rubex;Radiation: Strontium chloride Sr 89<br>* IV on day 1<br>* Other names: Strontium-89;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to prostate-specific antigen progression |  | Continuous assessment 16 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celebrex, recurrent prostate cancer, stage IV prostate cancer, bone metastases, Progressive Androgen-Independent Prostate Cancer, Metastron, Sr-89, Strontium-89, strontium chloride Sr 89, Celecoxib, Doxorubicin, Rubex, Adriamycin