Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer (NJLCG1402)
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000014893
- Lead Sponsor
- orth Japan Lung Cancer Study Group (NJLCG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 42
Not provided
1) Previous treatment with paclitaxel 2) Grade 2 or higher peripheral neuropathy 3) Active double cancer 4) Symptomatic brain metastases 5) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 6) Active infectious disease 7) Severe concurrent disease (intestinal paralysis, intestinal obstraction, poorly controlled diabetes, heart failure, renal failure, hepatic failure, active gastrointestinal ulceration, cardiac infarction within 6 months before enrollment, and grade 3 or higher angina so on) 8) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis. 9) Patient with autoimmune disease requiring immunosuppressive drugs 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Uncontrolled psychiatric disease 12) Patient are treated with steroid continuously 13) History of severe drug allergies. 14) Physician concludes that the patient's participation in this trial is inappropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of the maximum tolerated dose and recommended dose (Phase I) Response Rate (Phase II)
- Secondary Outcome Measures
Name Time Method Overall Survival Progression-free Survival Adverse Events Disease Control Rate