Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Society of Lung Cancer
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

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