Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000013390
- Lead Sponsor
- ational Hospital Organization Asahikawa Medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
(1) Previous treatment with paclitaxel (2) Patients who remain influence of prior treatment which disturb protocol treatment (3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Active infection requiring administration of systemic treatment with antibiotics. e.g. Body temperature rose higher than 38 degree centigrade 6) Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade 3 or higher angina 7) Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids 8) Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer 9) Confirmed or possible pregnancy, lactation, willingness to become pregnant (for women), or willingness to have a child (for men) 10) Psychiatric disorder or symptom that makes participation of the patient difficult 11) Continuous administration of a steroid 12) 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
- Secondary Outcome Measures
Name Time Method