Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

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 prostate cancer that has spread to the bones.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Abbott; Brigham and Women's Hospital; Dana-Farber Cancer Institute
• Treatments: Androgens; Atrasentan; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.