Trial | NCT00492843  Report issue

Title

Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis
A Randomized Study to Evaluate the Safety and Efficacy of Loading Dose of Bondronat Versus Standard Dose of Bondronat in Patients With Lung Cancer and Skeletal Metastasis Experiencing Moderate to Severe Pain

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    ibandronate ...

  • Study Participants

    20
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.
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.
Study Started
Jul 31
2007
Primary Completion
Jan 31
2008
Study Completion
Jul 31
2008
Last Update
Feb 17
2016
Estimate

Drug Ibandronate (Bondronat)

Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.

  • Other names: no other names

A Experimental

Intravenous infusion of either 6mg Bondronat on three consecutive days

B Active Comparator

Intravenous infusion of 6mg Bondronat on one day

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
No Results Posted