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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA090270 | U.S. NIH Grant/Contract | View source | |
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-02035 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000355360 | Registry Identifier | NCI PDQ |
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Low accrual due to competing trial.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I: Celecoxib | Experimental | 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. |
|
| Arm II: No Celecoxib | Experimental | Doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 + Strontium chloride Sr 89 IV on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Oral celecoxib twice daily in the absence of disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to prostate-specific antigen progression | Continuous assessment 16 weeks of treatment |
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DISEASE CHARACTERISTICS:
Diagnosis of androgen-independent prostate cancer
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Shi-Ming Tu, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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| Doxorubicin Hydrochloride | Drug | By vein (IV) over 30 minutes on days 1, 8, 15, and 22 |
|
|
| Strontium chloride Sr 89 | Radiation | IV on day 1 |
|
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D004317 | Doxorubicin |
| C025700 | strontium chloride |
| C000615489 | Strontium-89 |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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