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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Yilong Wu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangdong Provincial People's Hospital

Authority:

China: Food and Drug Administration

Study ID:

CSLC0701

NCT ID:

NCT00492843

Start Date:

July 2007

Completion Date:

July 2008

Related Keywords:

  • Lung Cancer
  • Ibandronate, Lung cancer, bone metastasis
  • Lung Neoplasms
  • Neoplasm Metastasis

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