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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ibandronate (Bondronat)
Sponsored by
Chinese Society of Lung Cancer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Ibandronate, Lung cancer, bone metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Intravenous infusion of either 6mg Bondronat on three consecutive days

Intravenous infusion of 6mg Bondronat on one day

Outcomes

Primary Outcome Measures

bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)

Secondary Outcome Measures

Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters

Full Information

First Posted
June 25, 2007
Last Updated
February 14, 2016
Sponsor
Chinese Society of Lung Cancer
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1. Study Identification

Unique Protocol Identification Number
NCT00492843
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
It is too difficult to recruit suitable patients.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Society of Lung Cancer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Ibandronate, Lung cancer, bone metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Intravenous infusion of either 6mg Bondronat on three consecutive days
Arm Title
B
Arm Type
Active Comparator
Arm Description
Intravenous infusion of 6mg Bondronat on one day
Intervention Type
Drug
Intervention Name(s)
Ibandronate (Bondronat)
Other Intervention Name(s)
no other names
Intervention Description
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Primary Outcome Measure Information:
Title
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yilong Wu, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Facility Name
The Tumor Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.lungca.com
Description
Related Info

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

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