Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer
- Conditions
- Clinical stage IV non squamous non small cell lung cancer chemotherapy naive patients over 70years old
- Registration Number
- JPRN-UMIN000004629
- Lead Sponsor
- Kumamoto university hospital
- Brief Summary
Oncology. 2015;88(4):201-7. doi: 10.1159/000369255. Epub 2014 Dec 6. Results Grade 3 infection as a dose-limiting toxicity was observed at a carboplatin dose of AUC 6. We therefore determined a carboplatin dose of AUC 5 and a pemetrexed dose of 500 mg/m2 as the recommended doses from this study. The pharmacokinetic study showed a significant inverse correlation between the AUC of pemetrexed and the creatinine clearance. Conclusions For elderly chemotherapy-naive patients with advanced nonsquamous NSCLC, the combination of carboplatin AUC 5 plus pemetrexed 500 mg/m2 is recommended as a promising regimen, however, a reduction of the pemetrexed dose may be required for patients with renal dysfunction because of the high risk of hematotoxicities.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 67
Not provided
Squamous cell carcinoma Radiation therapy to primary cancer SVC syndrome Severe drug allergy Severe pleural effusion or uncontrollable pleural effusion Severe ascites or pericardiac effusion Active infection Symptomatic brain metastasis Active concomitant malignancy Active mental illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method