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 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.

Condition	Treatment or Intervention
Breast Cancer Lung Cancer metastatic cancer Pain Prostate Cancer	Drug: ibandronate  Procedure: pain therapy  Procedure: radiation therapy  Procedure: supportive care/therapy

Further Study Details: 

OBJECTIVES: Primary

• Compare pain control at 4 and 12 weeks post-treatment in patients with localized metastatic bone pain treated with single-dose ibandronate vs single-dose local radiotherapy .

Secondary

• Compare the quality of life of patients treated with these regimens.
• Correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline) with the clinical outcome of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are stratified according to primary tumor type and participating center. Patients are randomized into 1 of 2 treatment arms.

• Arm I: Patients receive a single dose of local radiotherapy to the site of pain.
• Arm II: Patients receive a single dose of ibandronate IV over 1-2 hours. Patients who do not achieve a partial or complete response at 4 weeks crossover to the alternate arm.

Quality of life is assessed at baseline and then at 4 and 12 weeks. Pain is assessed at baseline, at 4, 8, and 12 weeks, and then at 6 months.

Patients are followed at 4, 8, and 12 weeks and then at 6 months.

PROJECTED ACCRUAL: A total of 580 patients (290 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary malignancy of the breast, lung, or prostate 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

• Not specified

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
• Not pregnant or nursing

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

United Kingdom, England
      Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge,  England,  CB2 2QQ,  United Kingdom; Recruiting
      Alexandra Healthcare NHS, Redditch, Worcestershire,  England,  B98 7UB,  United Kingdom; Recruiting
      Cancer Research Centre at Weston Park Hospital, Sheffield,  England,  S1O 2SJ,  United Kingdom; Recruiting
      Cancer Research UK and University College London Cancer Trials Centre, London,  England,  NW1 2ND,  United Kingdom; Recruiting
      Charing Cross Hospital, London,  England,  W6 8RF,  United Kingdom; Recruiting
      Churchill Hospital, Oxford,  England,  OX3 7LJ,  United Kingdom; Recruiting
      Clatterbridge Centre for Oncology NHS Trust, MERSEYSIDE,  England,  CH63 4JY,  United Kingdom; Recruiting
      Derbyshire Royal Infirmary, Derby,  England,  DE1 2QY,  United Kingdom; Recruiting
      Derriford Hospital, Plymouth,  England,  PL6 8DH,  United Kingdom; Recruiting
      Ealing Hospital NHS Trust, Southall Middlesex,  England,  UB1 3HW,  United Kingdom; Recruiting
      George Eliot Hospital, Nuneaton,  England,  CV10 7DJ,  United Kingdom; Recruiting
      Hammersmith Hospital, London,  England,  W12 OHS,  United Kingdom; Recruiting
      Ipswich Hospital NHS Trust, Ipswich,  England,  IP4 5PD,  United Kingdom; Recruiting
      Leicester Royal Infirmary, Leicester,  England,  LE1 5WW,  United Kingdom; Recruiting
      Lincoln County Hospital, Lincoln,  England,  LN2 5QY,  United Kingdom; Recruiting
      Mount Vernon Hospital, Northwood,  England,  HA6 2RN,  United Kingdom; Recruiting
      Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle upon Tyne,  England,  NE4 6BE,  United Kingdom; Recruiting
      Northwick Park Hospital, Harrow,  England,  HA1 3UJ,  United Kingdom; Recruiting
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom; Recruiting
      Oldchurch Hospital, Romford,  England,  RM7 OBE,  United Kingdom; Recruiting
      Pilgrim Hospital, Boston,  England,  PE21 9QT,  United Kingdom; Recruiting
      Portsmouth Oncology Centre at Saint Mary's Hospital, Portsmouth Hants,  England,  PO3 6AD,  United Kingdom; Recruiting
      Princess Royal Hospital, Hull,  England,  HU8 9HE,  United Kingdom; Recruiting
      Royal Devon and Exeter Hospital, Exeter,  England,  EX2 5DW,  United Kingdom; Recruiting
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting
      Royal Sussex County Hospital, Brighton,  England,  BN2 5BF,  United Kingdom; Recruiting
      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom; Recruiting
      Southampton General Hospital, Southampton,  England,  SO16 6YD,  United Kingdom; Recruiting
      St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford,  England,  GU2 5XX,  United Kingdom; Recruiting
      St. Mary's Hospital, London,  England,  W2 1NY,  United Kingdom; Recruiting
      Walsgrave Hospital, Coventry,  England,  CV2 2DX,  United Kingdom; Recruiting
United Kingdom, Wales
      Velindre Cancer Center at Velinde Hospital, Cardiff,  Wales,  CF14 2TL,  United Kingdom; Recruiting

Study chairs or principal investigators

Orla Cummins,  Study Chair,  Cancer Research UK   

Study ID Numbers:  CDR0000361728; CRUK-NCRI-RT-02-01; EU-20224; RIB; ISRCTN86185157; NCT00082927
Record last reviewed:  April 2004
Last Updated:  April 5, 2005
Record first received:  May 14, 2004
ClinicalTrials.gov Identifier:  NCT00082927
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08