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

Sponsor:	Chinese Society of Lung Cancer
Information provided by:	Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:	NCT00492843

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: Ibandronate (Bondronat)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Chinese Society of Lung Cancer:

Primary Outcome Measures:

bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Intravenous infusion of either 6mg Bondronat on three consecutive days	Drug: Ibandronate (Bondronat) Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
B: Active Comparator Intravenous infusion of 6mg Bondronat on one day	Drug: Ibandronate (Bondronat) Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492843

Locations

China
Sun Yat-sen University Cancer Center
Guangzhou, China
Shanghai Pulmonary Hospital
Shanghai, China
Beijing Cancer Hospital
Beijing, China
Shanghai Chest Hospital
Shanghai, China
The Tumor Hospital of Harbin Medical University
Harbin, China
General Hospital of Tianjin Medical University
Tianjin, China
China, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China

Sponsors and Collaborators

Chinese Society of Lung Cancer

Investigators

Principal Investigator:

Yilong Wu, MD

Guangdong Provincial People's Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Chinese Society of Lung Cancer ( Chinese Society of Lung Cancer )
Study ID Numbers:	CSLC0701
Study First Received:	June 25, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00492843 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Chinese Society of Lung Cancer:

Ibandronate, Lung cancer, bone metastasis

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes

Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Ibandronic acid
Lung Neoplasms
Lung Diseases
Neoplasm Metastasis

ClinicalTrials.gov processed this record on February 08, 2010