Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.
Phase 2
- Conditions
- Stage IIIB/IV non-small cell lung cancer
- Registration Number
- JPRN-UMIN000001225
- Lead Sponsor
- The Japan-multinational Trial Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with serious infections or suspected infections with fever. 2)Pregnant or lactating women 3)Active concomitant malignancy 4)Past history of allergic reactions to polysorbate 80 5)Patients with interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray 6)Patients with inadequately controlled complications such as hypertension, congestive heart failure, myocardial infarction, arrhythmia, bleeding and diabetes. 7)Clinically significant pleural/pericardial effusion which requires treatment 8)Symptomatic brain metastases 9)Grade 2 or greater peripheral neuropathy 10)Patients judged by the investigator as unfit to be enrolled in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method Response rate, 1-yr survival, overall survival, safety