Clinical trial NCT00492843: Loading Dose or Standard Dose of Intravenous Ibandronate in Treating Patients With Lung Cancer and Skeletal Metastasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lung Cancer
Keywords: Ibandronate, Lung cancer, bone metastasis
Lead sponsor: Chinese Society of Lung Cancer
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
timeFrame: 1 month
Secondary outcomes:
measure: Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
timeFrame: 1 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Harbin
country: China
facility: The Tumor Hospital of Harbin Medical University
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: