Study Stopped
It is too difficult to recruit suitable patients.
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
1 other identifier
interventional
20
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 lung-cancer
Started Jul 2007
Shorter than P25 for phase_4 lung-cancer
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFebruary 17, 2016
February 1, 2016
6 months
June 25, 2007
February 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
1 month
Secondary Outcomes (1)
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
1 month
Study Arms (2)
A
EXPERIMENTALIntravenous infusion of either 6mg Bondronat on three consecutive days
B
ACTIVE COMPARATORIntravenous infusion of 6mg Bondronat on one day
Interventions
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Patient who are currently treated with any other investigational therapy or have received it within 30 days of the first schedule day of dosing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The Tumor Hospital of Harbin Medical University
Harbin, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
General Hospital of Tianjin Medical University
Tianjin, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yilong Wu, MD
Guangdong Provincial People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
July 1, 2007
Primary Completion
January 1, 2008
Study Completion
July 1, 2008
Last Updated
February 17, 2016
Record last verified: 2016-02