Lung Cancer
Conditions
Keywords
Ibandronate, Lung cancer, bone metastasis
Brief summary
The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
Detailed description
Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.
Interventions
DRUGIbandronate (Bondronat)
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Sponsors
Chinese Society of Lung Cancer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age ≥ 18 years * Histological or cytological evidence of lung cancer * Presence of bone metastases documented on bone X-ray, bone ECT, CT scan or MRI scan * Mean pain score ≥ 4 during 3-day baseline period on the WORSE pain scale of the VAS * Patients must be on a stable dose of analgesics over the 3-day baseline period (maximum 15% variation is allowed) * ECOG Performance status of 0-3 (patients with PS of 3 must have their score based on bone pain, not underlying neoplastic disease) * Adequate renal function: creatinine clearance ≥ 50 ml/min (cockroft formula) and serum creatinine ≤ 2.0mg/dl (168 µmol/L); ALT or AST within 2 times the upper limit of the normal range
Exclusion criteria
* Patients with an uncontrolled infection * Hypocalcemia * Patients who have received a bisphosphonate within 3 weeks of the start of the Baseline period or who are currently receiving another bisphosphonate * Patients with known hypersensitivity to any of the components of ibandronic acid * Patients who are pregnant or lactating * Radiotherapy to bone within the 28 days prior inclusion or during the trial duration * Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters | 1 month |
Countries
China
Outcome results
None listed