Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain.

PURPOSE: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary prostate cancer OR sclerotic bone metastases (for patients with serum prostate-specific antigen > 100 ng/mL)

• Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI

• Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated

• Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• Over 18

Sex

• Male

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 3 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine ≤ 3.0 mg/dL

• No hypercalcemia (corrected calcium > 10.8 mg/dL)

• No hypocalcemia (corrected calcium < 8.2 mg/dL)

Other

• No known hypersensitivity to ibandronate or other bisphosphonates

• No history of aspirin-sensitive asthma

• Able to comply with pain chart and quality of life assessments

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 weeks since prior change in systemic chemotherapy

• No prior high-dose chemotherapy (dose intensity > 3 times standard dose)

Endocrine therapy

• More than 4 weeks since prior change in hormonal therapy

Radiotherapy

• See Disease Characteristics

• No prior external beam radiotherapy to index site

• No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)

Surgery

• Not specified

Other

• More than 6 months since prior bisphosphonate treatment

• More than 4 weeks since prior aminoglycoside antibiotics

• More than 30 days since prior investigational drugs