Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
Phase 1
Recruiting
- Conditions
- on-small-cell lung cancer
- Registration Number
- JPRN-UMIN000014544
- Lead Sponsor
- Shizuoka cancer center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
1) Symptomatic brain metastasis 2) Interstitial pneumonia with usual interstitial pneumonia pattern on chest CT 3) Grade 2 or more peripheral sense neuropathy 4) With uncontrolled pleural effusion, ascites or pericardial effusion 5) Treated with palliative radiotherapy within the past two weeks 6) Active concomitant malignancy 7) Severe complication 8) HBs antigen positive 9) Previous severe drug allergy 10) Continuous systemic administration of steroid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Dose limiting toxicity Phase II: Progression free survival
- Secondary Outcome Measures
Name Time Method Phase I: Adverse event, Response rate Phase II: Adverse event, Response rate, Overall survival