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

This study has been terminated.
(It is too difficult to recruit suitable patients.)
Sponsor:
Information provided by:
Chinese Society of Lung Cancer
ClinicalTrials.gov Identifier:
NCT00492843
First received: June 25, 2007
Last updated: June 9, 2008
Last verified: June 2008
  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 4

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


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
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 Name: 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 Name: no other names

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China, Guangdong
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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
Sponsors and Collaborators
Chinese Society of Lung Cancer
Investigators
Principal Investigator: Yilong Wu, MD Guangdong Provincial People's Hospital
  More Information

No publications provided

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

Keywords provided by Chinese Society of Lung Cancer:
Ibandronate, Lung cancer, bone metastasis

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Lung Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Ibandronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014