Status:
COMPLETED
Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Novartis
Conditions:
Bone Metastases
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help prevent calc...
Detailed Description
Bone metastases are frequently one of the first signs of disseminated disease in cancer patients. Skeletal complications due to metastatic disease include (severe) bone pain, impaired mobility, spinal...
Eligibility Criteria
Inclusion
- \>18 years of age
- biopsy proven breast, lung, and/or prostate cancer
- boney metastases with an indication for radiation, either diagnosed radiologically or biopsy proven
- Karnofsky Performance Status \>60
- Life expectancy of at least 6 months
- Serum creatinine level ≤ 2.0 mg/dL and calculated creatinine clearance of \> 60 mL/min
- Leukocyte count ≥ 3500/mm3
- Hemoglobulin \> 11 g/dl
- Platelets \> 100,000 / mm3
- Total bilirubin \< 2.5 mg/dl
Exclusion
- pregnant and lactating women (breast and lung cancer)
- hormonotherapy started less than 3 months prior to randomization (prostate cancer)
- history of allergic reactions to bisphosphonates
- receiving concomitant nephrotoxic chemotherapy
- participation in another clinical trial with an investigational drug or completed an investigational drug trial within the past 30 days
- liver function tests \> 1.5 times normal values
- IV calcitonin administration less than 30 days prior to randomization
- laboratory evidence of renal disease
- previous RT to the region of bone metastasis which will be treated in this study
- currently receiving oral or IV bisphosphonate therapy
- presence of ascites
- clinically significant electrocardiographic changes
- hypercalcemia, pathologic fracture, or epidural spinal cord compression
- other organ metastasis
- known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
- current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00264420
Start Date
December 1 2005
End Date
March 1 2007
Last Update
December 21 2010
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