title: Phase I study of combination chemotherapy with gemcitabine and irinotecan for non-small cell lung cancer.
abstract: A phase I study combining a fixed dose of gemcitabine with differing doses of CPT-11 every two weeks for previously treated non-small cell lung cancer (NSCLC) patients.
  
  
  METHODS
  A total of 21 patients with previously treated non-small cell lung cancer were treated every two weeks with CPT-11 followed by gemcitabine. The gemcitabine dose was fixed at 1000 mg/m2. The starting dose of CPT-11 (50 mg/m2) was then escalated different patients in 25 mg/m2 increments until 150 mg/m2 (level 5), the recommended dose as a single agent in Japan.
  
  
  RESULTS
  Dose-limiting toxicity was only observed at level 5, in three of nine patients receiving the highest dose of CPT-11. One patient had grade 3 diarrhea, and two could not continue chemotherapy with grade 1 diarrhea or grade 1 neutropenia on day 15. Hematologic toxicity with this combination regimen, however, was generally mild. No grade 4 neutropenia, and only one case of grade 3 leukopenia was noted at level 5. Compliance with the combination regimen was good and there was no cumulative toxicity with the subsequent courses. Twenty-five courses of therapy were given at level 5 and the percentage of actual delivered doses/planned doses was 82%.
  
  
  CONCLUSIONS
  The combination chemotherapy has only very mild toxicity and dose which can be recommended with this regimen are 1000 mg/m2 for gemcitabine and 150 mg/m2 for CPT-11 every two weeks.
authors.affiliation: Division of Internal Medicine, Cancer Institute Hospital, Japanese Foundation For Cancer Research, Kami-ikebukuro 1-37-1, Toshima-ku, Tokyo 170-8455, Japan. mnishio@jfcr.or.jp
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.forename: Fumiyoshi
authors.initials: F
authors.lastname: Ohyanagi
authors.forename: Fumiko
authors.initials: F
authors.lastname: Taguch
authors.forename: Masanori
authors.initials: M
authors.lastname: Matsuda
authors.forename: Yukitohi
authors.initials: Y
authors.lastname: Sato
authors.forename: Sakae
authors.initials: S
authors.lastname: Okumura
authors.forename: Ken
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Horai
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000077146:Irinotecan; D002166:Camptothecin; D000093542:Gemcitabine