Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases

UMIN ID: UMIN000000735

Registered date:07/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer with bone metastases
• Date of first enrollment: 2007/06/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Zoledronic acid 4mg, day1 Docetaxel 60mg/m2, day1 Cisplatin 80mg/m2, day1 every 3 to 4 weeks

Outcome(s)

• Primary Outcome: feasibility
• Secondary Outcome: response rate, skeletal-related event, overall survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Emergency of radiotherapy to bone metastases 2. No prior bisphosphonates for cancer 3. Uncontrolled pleural or pericardial effusion 4. Symptomatic brain metastasis 5. Active infection 6. Severe odontopathy 7. Interstitial pneumonia/active lung fibrosis on chest x-ray 8. Active concomitant malignancy 9. Pregnant or lactating women 10. Severe drug-allergy 11. Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding

Related Information

• Primary Sponsor: Thoracic Oncology Division, National Cancer Center Hospital East
• Source(s) of Monetary Support: Thoracic Oncology Division, National Cancer Center Hospital East