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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00492843
• Other study ID #: CSLC0701
• Status: Terminated
• Phase: Phase 4
• First received: June 25, 2007
• Last updated: February 14, 2016
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2016
• Source: Chinese Society of Lung Cancer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Ibandronate (Bondronat)
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Society of Lung Cancer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone pain response (=25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)		1 month	No
Secondary	Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters		1 month	Yes