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Clinical Trial Name - Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Andro

 
Original Study ID : CDR0000355360
Secondary ID : MDA-ID-02035
NCT ID : NCT00080782
Brief Title : Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
Official Title : A Randomized Phase II Trial of Bone-Targeted Therapy Consisting of Strontium-89 and Doxorubicin With or Without Celecoxib in Androgen-Independent Prostate Cancer
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.

Source : National Cancer Institute (NCI)
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.

Overall Status : Active, not recruiting
Start Date : February 2002
Official Title : Phase 2
Phase : Interventional
Study Design : Treatment, Randomized, Active Control
Enrollment : 70
Verification Date : October 2006
First Received Date : April 7, 2004
Trial Eligibility
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
Gender : Male
Minimum Age : N/A
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : M.D. Anderson Cancer Center at University of Texas
City : Houston
State : Texas
Zip Code : 77030-4009
Country : United States
OutComes
Primary OutComes
Measure : Time to prostate-specific antigen progression
Safety issue : No
Interventions
Type : Drug
Name : celecoxib
Type : Drug
Name : doxorubicin hydrochloride
Type : Radiation
Name : strontium chloride Sr 89
 
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