Phase II study for efficacy and safety of nab-paclitaxel and carboplatin combination chemotherapy for Previously untreated advanced non-small cell lung cancer
- Conditions
- non-small cell lung cancer
- Registration Number
- JPRN-UMIN000010738
- Lead Sponsor
- Tokyo Metropolitan Cancer and Infection diseases Center Komagome Hospital
- Brief Summary
RESULTS: The study was interrupted early because of two treatment-related deaths and 1 life-threatening severe adverse event; therefore, only 10 patients (median age, 77 years; range 71-82 years) were enrolled. The primary end point of the objective response was 50 % for the 10 patients analyzed. Progression-free survival was 4.48 months [95 % confidence interval (CI) 0.36-6.44], and overall survival was 7.89 months (95 % CI 0.36-26.88). Common treatment-related adverse events higher than grade 2 included decreased neutrophil counts, anemia, decreased albumin, anorexia, and peripheral neuropathy. Regarding severe adverse events, two patients had febrile neutropenia and lung infection. Two patients died, and one patient had febrile neutropenia with intubation during the first cycle. The Data and Safety Monitoring Committee therefore recommended interruption of patient enrollment. CONCLUSION: Nab-paclitaxel plus carboplatin, without dose reduction, is indicated to be toxic and intolerable as first-line chemotherapy in elderly Japanese patients with advanced NSCLC. Care must be taken when extrapolating the results of a clinical trial into clinical practice, particularly when the resulting subgroup analysis is of elderly patients because this patient group is composed of a heterogeneous population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 38
Not provided
1) The age of less than 70 years-old 2) Previously treated with chemotherapy 3) With uncontrolled brain metastasis 4) With clinically active infection 5) With severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes) 6) With uncontrolled pleural effusion 7) With active other organ cancer 8) With the history of severe drug allergy 9) With the history of hypersensivity for paclitaxel, albumin-containing agents 10) With the history of hypersensitivity for platinum agents 11) With uncontrolled digestive ulcer 12) Any patients judged by the investigator to be unfit to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method progression-free survival, overall survival, toxicities, number of cycles