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

Condition(s) targeted: Metastatic Cancer; Pain; Prostate Cancer

Intervention: ibandronate sodium (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Cancer Research UK

Official(s) and/or principal investigator(s):
Heather Purnell, Affiliation: Cancer Research UK
Katherine Monson, Affiliation: Cancer Research UK

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.

Official title: A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain

Study design: Supportive Care, Randomized, Open Label, Active Control

Detailed description: OBJECTIVES:

Primary

- Compare pain response 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

(8Gy/1f).

- Arm II: Patients receive a single dose of ibandronate IV over 15 minutes. 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 and 12 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this study.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Alexandra Healthcare NHS, Redditch, Worcestershire, England B98 7UB, United Kingdom; Recruiting
Clive J. Irwin, Phone: 44-015-2750-3030

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, England RG24 9NA, United Kingdom; Recruiting
Contact Person, Phone: 44-148-340-5823

Bristol Haematology and Oncology Centre, Bristol, England BS2 8ED, United Kingdom; Recruiting
Contact Person, Phone: 44-117-928-2409

Cancer Care Centre at York Hospital, York, England Y031 8HE, United Kingdom; Recruiting
Contact Person, Phone: 44-014-2355-5453

Cancer Research UK and University College London Cancer Trials Centre, London, England NW1 2ND, United Kingdom; Recruiting
Contact Person, Phone: 44-207-679-8036

Charing Cross Hospital, London, England W6 8RF, United Kingdom; Recruiting
Simon Stewart, MD, Phone: 44-20-8846-7659, Email: s.stewart@ic.ac.ak

Clatterbridge Centre for Oncology, Merseyside, England CH63 4JY, United Kingdom; Recruiting
Isabel Syndikus, MD, Phone: 44-151-334-1155 ext. 4748

Conquest Hospital, Saint Leonards-on-Sea, England TN37 7RD, United Kingdom; Recruiting
Contact Person, Phone: 44-142-475-8391

Cumberland Infirmary, Carlisle, England CA2 7HY, United Kingdom; Recruiting
Contact Person, Phone: 44-122-881-4345

Diana Princess of Wales Hospital, Grimsby, England DN33 2BA, United Kingdom; Recruiting
Contact Person, Phone: 44-147-287-4111

Eastbourne District General Hospital, Eastbourne, England BN21 2UD, United Kingdom; Recruiting
Contact Person, Phone: 44-132-341-7400 ext 5813

Essex County Hospital, Colchester, England C03 3NB, United Kingdom; Recruiting
Contact Person, Phone: 44-120-6744636

George Eliot Hospital, Nuneaton, England CV10 7DJ, United Kingdom; Recruiting
Contact Person, Phone: 44-024-769-67474

Harrogate District Hospital, Harrogate, England HG2 7SX, United Kingdom; Recruiting
Contact Person, Phone: 44-142-355-5453

Kent and Canterbury Hospital, Canterbury, England CT1 3NG, United Kingdom; Recruiting
Contact Person, Phone: 44-122-776-6877

Kidderminster Hospital, Kidderminster Worcestershire, England DY11 6RJ, United Kingdom; Recruiting
Contact Person, Phone: 44-156-253-802

King's Mills Hospital, Nottinghamshire, England NG17 4JL, United Kingdom; Recruiting
Contact Person, Phone: 44-115-1169 ext. 54690

Leeds Cancer Centre at St. James's University Hospital, Leeds, England LS9 7TF, United Kingdom; Recruiting
Contact Person, Phone: 44-113-392-4206

Lincoln County Hospital, Lincoln, England LN2 5QY, United Kingdom; Recruiting
Thiagarajan Sreenivasant, Phone: 44-152-257-7203

Mayday University Hospital, Croydon, England, United Kingdom; Recruiting
Contact Person, Phone: 44-208-661-3269

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom; Recruiting
Peter J. Hoskin, MD, Phone: 44-019-2384-4533

Musgrove Park Hospital, Taunton, England TA1 5DA, United Kingdom; Recruiting
Contact Person, Phone: 44-0182-334-2418

New Cross Hospital, Wolverhampton, England WV10 0QP, United Kingdom; Recruiting
Contact Person, Phone: 44-019-0269-5207

North Devon District Hospital, Barnstaple, England EX31 4JB, United Kingdom; Recruiting
Contact Person, Phone: 44-127-131-1538

Northampton General Hospital NHS Trust, Northampton, England NN1 5BD, United Kingdom; Recruiting
Contact Person, Phone: 44-160-454-5246

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom; Recruiting
Contact Person, Phone: 44-115-969-1169 ext. 54690

Oldchurch Hospital, Romford, England RM7 OBE, United Kingdom; Recruiting
A. Alsafer, MD, Phone: 44-1708-746-090

Queen's Hospital, Burton-upon-Trent, England DE13 0RB, United Kingdom; Recruiting
Contact Person, Phone: 44-128-356-6333 ext. 5465

Royal Devon and Exeter Hospital, Exeter, England EX2 5DW, United Kingdom; Recruiting
Denise J. Sheehan, MD, Phone: 44-1392-411-611

Royal Marsden - London, London, England SW3 6JJ, United Kingdom; Recruiting
Contact Person, Phone: 44-1392-411-611

Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom; Recruiting
Alan Horwich, MD, PhD, FRCP, FRCR, Phone: 44-20-8661-3274

Royal Shrewsbury Hospital, Shrewsbury, England SY3 8XQ, United Kingdom; Recruiting
Contact Person, Phone: 44-0174-326-1656

Royal United Hospital, Bath, England BA1 3NG, United Kingdom; Recruiting
Contact Person, Phone: 44-122-582-1522

Russells Hall Hospital, Dudley, England DY1 2HQ, United Kingdom; Recruiting
Contact Person, Phone: 44-128-484-5611 ext. 2219

Sandwell General Hospital, West Bromwich, England B71 4HJ, United Kingdom; Recruiting
Conact Person, Phone: 44-012-1472-1311

Scarborough General Hospital, Scarborough, England YO12 6QL, United Kingdom; Recruiting
Contact Person, Phone: 44-014-270-1151

Scunthorpe General Hospital, Scunthorpe, England DN15 7BH, United Kingdom; Recruiting
Contact Person, Phone: 44-172-429-0180

Southampton General Hospital, Southampton, England SO16 6YD, United Kingdom; Recruiting
Contact Person, Phone: 44-238-079-8657

St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England GU2 7XX, United Kingdom; Recruiting
Marianne Illsley, Phone: 44-1483-571-122

St. Mary's Hospital, London, England W2 1NY, United Kingdom; Recruiting
Contact Person, Phone: 44-207-886-1132

Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England BN2 5BF, United Kingdom; Recruiting
David Bloomfield, MD, Phone: 44-1273-696-955 ext. 7686

Torbay Hospital, Torquay, England TQ2 7AA, United Kingdom; Recruiting
Contact Person, Phone: 44-018-0365-5381

Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom; Recruiting
Contact Person, Phone: 44-24-7653-5986

Warrington Hospital NHS Trust, Warrington, England WA5 1QG, United Kingdom; Recruiting
Contact Person, Phone: 44-015-334-1155 ext. 4801

Warwick Hospital, Warwick, England CV34 5BW, United Kingdom; Recruiting
Contact Person, Phone: 44-247-96-7483

West Cumberland Hospital, Whitehaven, England CA28 8JG, United Kingdom; Recruiting
Contact Person, Phone: 44-122-881-4245

Weston General Hospital, Weston-super-Mare, England BS23 4TQ, United Kingdom; Recruiting
Contact Person, Phone: 44-019-3464-7186

William Harvey Hospital, Ashford-Kent, England TN24 0LZ, United Kingdom; Recruiting
Contact Person, Phone: 44-122-776-6877

Worthing Hospital, Worthing, England BN11 2DH, United Kingdom; Recruiting
Contact Person, Phone: 44-019-032-5111 ext. 4225

Yeovil District Hospital, Yeovil, England BA21 4AT, United Kingdom; Recruiting
Contact Person, Phone: 44-011-7928-2419

Ninewells Hospital, Dundee, Scotland DD1 9SY, United Kingdom; Recruiting
Contact Person, Phone: 44-138-242-5543

Glan Clwyd Hospital, Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom; Recruiting
Contact Person, Phone: 44-017-4544-5155

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2003
Last updated: June 16, 2009