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

Condition(s) targeted: Lung Cancer

Intervention: Ibandronate (Bondronat) (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Chinese Society of Lung Cancer

Official(s) and/or principal investigator(s):
Yilong Wu, MD, Principal Investigator, Affiliation: Guangdong Provincial People's Hospital

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Sun Yat-sen University Cancer Center, Guangzhou, China

Shanghai Pulmonary Hospital, Shanghai, China

Beijing Cancer Hospital, Beijing, China

Shanghai Chest Hospital, Shanghai, China

The Tumor Hospital of Harbin Medical University, Harbin, China

General Hospital of Tianjin Medical University, Tianjin, China

Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510080, China

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Starting date: July 2007
Ending date: July 2008
Last updated: June 9, 2008