Status:
COMPLETED
Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Prostate Cancer
Adenocarcinoma of the Prostate
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with pro...
Detailed Description
* Patients will be randomized to either receive Atrasentan alone or Atrasentan plus Zometa. * Patients receiving Atrasentan alone will receive this drug in pill form once daily for 12 weeks. Patients ...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- History of bilateral orchiectomy or current treatment with a GnRH agonist or antagonist
- Radiographically documented bone metastases
- Disease progression according to criteria from the PSA Working Group
Exclusion
- Prior treatment with Atrasentan or Zometa within one year
- Serum creatinine \> 2.0mg/dL
- Documented cardiovascular disability status of New York Heart Association Class 2
- Treatment with chemotherapy, radiation, steroids, estrogens, or PC-SPES within 6 weeks
- Treatment with bisphosphonates or radiopharmaceuticals within 12 weeks
- History of Paget's disease, hyperthyroidism, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia or other disorder associated with metabolic bone disease.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00181558
Start Date
December 1 2001
End Date
December 1 2006
Last Update
May 10 2010
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115