Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 calcium level elevations in the blood. Cancer cell-culture studies at the Cleveland Clinic showed that zoledronic acid and radiation together have more cell killing effect than either one used alone. The purpose of this study is to monitor the healing of bone lesions when using zoledronic acid together with radiation treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Novartis
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• >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 Criteria:

• 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)