© 2007 Foundation for Promotion of Cancer Research
Phase I Study of Irinotecan and Gemcitabine in Previously Untreated Patients with Advanced Non-small Cell Lung Cancer
1 Department of Internal Medicine, Nagasaki Municipal Hospital, Nagasaki
2 Second Department of Internal Medicine, Nagasaki University School of Medicine
3 National Nagasaki Medical Center
4 Japanese Red-Cross Nagasaki Atomic Bomb Hospital
5 Sasebo General Hospital, Nagasaki
6 Division of Respiratory Disease, Department of Medicine, Kawasaki Medical School, Okayama
7 National Ureshino Hospital, Saga, Japan
For reprints and all correspondence: Hiroshi Soda, Second Department of Internal Medicine, Nagasaki University School of Medicine, 1-7-1 Sakamoto, Nagasaki 852-8501, Japan. E-mail: h-souda{at}hospital.sasebo.nagasaki.jp
Received October 2, 2006; accepted January 15, 2007
Background: Irinotecan and gemcitabine are effective against non-small cell lung cancer. We conducted a phase I study of the combined use of irinotecan and gemcitabine in previously untreated patients with advanced non-small cell lung cancer to determine dose-limiting toxicities and maximum tolerated dose.
Methods: Patients were treated with irinotecan followed by gemcitabine on days 1 and 8 every 3 weeks. Gemcitabine dose was fixed at 1000 mg/m2, and irinotecan dose was increased from 60 mg/m2.
Results: A total of 16 patients was enrolled. Maximum tolerated dose of irinotecan was determined up to level 3 (irinotecan 100 mg/m2). In Japan, the maximum approved weekly dose of irinotecan is 100 mg/m2, so this was the dose that was used. Only very mild hematological and non-hematological toxicities were noted.
Conclusion: Use of 100 mg/m2 irinotecan followed by 1000 mg/m2 gemcitabine on days 1 and 8 every 3 weeks warrants a phase II study.
Key Words: non-small cell lung cancer – chemotherapy – irinotecan • gemcitabine