Status:
TERMINATED
Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
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 ...
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 chlori...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00080782
Start Date
February 1 2002
End Date
January 1 2005
Last Update
October 31 2018
Active Locations (1)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009