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



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

For Condition: stage 4 prostate cancer,bone metastases,recurrent prostate cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to compare the effectiveness of doxorubicin and strontium-89 with or without celecoxib in treating patients who have progressiveandrogen-independent prostate cancer and bone metastases.
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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Shi-MingTu,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Shi-Ming  Tu 713-792-2830


Additional Information:
Study ID Numbers:
  CDR0000355360;  MDA-ID-02035
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080782

Other Bone Metastases Studies:
1. Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy

2. Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

3. MLN2704 in Treating Patients With Progressive Metastatic Prostate Cancer

4. Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy

5. Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer

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