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

February 14, 2016 updated by: Yi-Long Wu, Chinese Society of Lung Cancer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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.
Other Names:
  • no other names
Active Comparator: B
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.
Other Names:
  • no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Society of Lung Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 14, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSLC0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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