Non small cell lung cancer (NSCLC)
Conditions
Interventions
Ibandronic acid 6 mg i.v. infusion over 15 minutes Days 1, 2, and 3.
Sponsors
NVALT-oncology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with MBD due to histology or cytology confirmed NSCLC; 2. MBD confirmed by bone scintigraphy, MRI, CT-scan, PET scan or X-ray or cytohistological proven; 3. mean bone pain score „d 5 over the last 7 days on the WORST PAIN scale on the BPI; 4. bone pain must correspond to areas of metastases on bone scintigraphy, MRI, CT-scan, PET scan or X-ray. It is the investigators responsibility to insure that the pain is mainly due to MBD; 5. the use of at least a NSAID or a weak opioid based on the WHO analgesic ladder step 2; 6. no indication for radiotherapy for myelum compression; 7. adequate renal function (creatinine clearance as calculated by Cockroft-Gault method > 50 ml/min); 8. life expectancy at least 1 month; 9. age > 18 years; 10. written informed consent; 11. able to comply with study measurements i.e. brief pain inventory and QoL assessments.
Exclusion criteria
Exclusion criteria: 1. Other active malignancies; 2. nursing mothers; 3. pregnancy; 4. patients with impending pathological fracture or spinal cord compression; 5. bone radiotherapy in the preceding 4 weeks; 6. bisphosphonate treatment in the previous 2 months; 7. hypercalcemia (serum calcium, albumin corrected „d 2.7 mmol/l); 8. hypocalcemia (serum calcium, albumin corrected < 2 mmol/l); 9. primary hyperparathyroidism; 10. known Paget¡¦s disease of the bone; 11. start of anti tumor treatment in 4 weeks before study entry; 12. patients with known hypersensitivity to any of the components of ibandronic acid; 13. delirium or confusion; 14. treatment with aminoglycoside antibiotics < 4 weeks before start study treatment; 15. start or increase of dose of corticosteroids in preceding week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to establish the efficacy of ibandronic acid in patients with lung cancer and painful metastatic bone disease and pain responses over a 7 day period. The main efficacy endpoint is bone pain response. In this study, pain response is defined as a: 25% decrease in mean pain score over a 3-day period (day 5,6 and 7) compared to pain score at baseline as determined by the “WORST PAIN” scale of the Brief Pain Inventory (BPI), with no more than a 25% increase in mean analgesic consumption over the same 3-day period compared to mean Baseline analgesic consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean WORST PAIN scale of the BPI over time (first 7 days); 2. Interference scales of the BPI (individually and total score); 3. Analgesic consumption, expressed as Opioid equivalents; 4. WHO performance score; 5. QoL assessment; 6. Safety. | — |
Contacts
Public ContactD.J. Storm
NVALT Datacenter NKI-AVL Plesmanlaan 121
Outcome results
None listed