Phase II study of docetaxel, cisplatin, and zoledronic acid for advanced non-small cell lung cancer with bone metastases
Phase 2
- Conditions
- non-small cell lung cancer with bone metastases
- Registration Number
- JPRN-UMIN000000735
- Lead Sponsor
- Thoracic Oncology Division, National Cancer Center Hospital East
- Brief Summary
The combination of Zoledronic Acid, cisplatin and docetaxel is well tolerated with acceptable renal toxicity and has modest activity as the first-line treatment of NSCLC patients with bone metastases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method feasibility
- Secondary Outcome Measures
Name Time Method response rate, skeletal-related event, overall survival, adverse events