Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-UMIN000010532
- Lead Sponsor
- Department of Respiratory Medicine , Kumamoto University School of Medicine
- Brief Summary
ung Cancer 2016, in press Results: Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7 % (90% confidence interval, 19.3% to 44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4 to 7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0 to 18.0 months) months. The median number of treatment cycles was four (range, 1 to 17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion: Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 41
Not provided
1) Anamnesis of hypersensitivity to paclitaxel or albumin 2) Treatment history of taxanes (recurrence after more than one year from adjuvant chemotherapy including taxanes is permitted.) 3) Patient received chemotherapy within 4 weeks or EGFR-TKI within 2 weeks. 4) Patient received curative radiotherapy within 6 weeks or regional palliative radiotherapy within 2weeks. 5) Patient received operation within 4 weeks or surgical open within 2 weeks. 6) Symptomatic brain metastasis 7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 8) Active infectious disease in need of systemic administration of anti-bacterial drugs 9) Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on) 10) Patient needed to be administered with immunosuppressive drugs such as azathioprine , cyclophosphamide , methotrexate , or steroid 11) Active double cancer within 5 years of disease free interval (but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer ,by endoscopic mucosal resection , curative cutaneous cancer except for malignant melanoma ) 12) Peripheral neuropathy Grade2 or over 13) Pregnancy or lactating patients , or no intention to practice birth control. 14) Uncontrolled psychiatric disease 15) Physician judged improper to entry this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method