title: Phase I study of carboplatin, docetaxel and irinotecan with recombinant human granulocyte colony stimulating factor support in patients with advanced non-small cell lung cancer.
abstract: A phase I study was conducted in patients with stage IIIB or IV non-small cell lung cancer to determine the maximum tolerated dose (MTD) of irinotecan combined with a fixed schedule of docetaxel and carboplatin with recombinant human granulocyte colony stimulating factor (rhG-CSF) (nartograstim) support. Docetaxel was given at 60 mg/m2 on day 1 with carboplatin. The dose of carboplatin was calculated using the Calvert formula to achieve an estimated AUC of 5.0 mg/ml x min. Irinotecan was administered at a starting dose of 40 mg/m2 on day 1 and increased in increments of 10 mg/m2. rhG-CSF was given at 1 microg/kg on days 5-15. Cycles were repeated every 3 weeks. Between February 1998 and March 1999, 22 patients were enrolled in this phase I study. Five patients were chemotherapy naive. The MTD of irinotecan was 60 mg/m2. Diarrhea was considered to be the dose-limiting toxicity. The irinotecan dose intensity of 16.7 mg/m2/week was low compared with other irinotecan-containing regimens. The overall response rate was 38.1% and median survival was 278 days. Irinotecan 50 mg/m2 in combination with 60 mg/m2 docetaxel and carboplatin on day 1 with rhG-CSF support is recommended for phase II study. The response rate and survival data in this phase I study are encouraging.
authors.affiliation: Division of Respiratory Disease, Minami-ichijo Hospital, Sapporo, Japan. afujita@sa2.so-net.ne.jp
authors.forename: A
authors.initials: A
authors.lastname: Fujita
authors.forename: H
authors.initials: H
authors.lastname: Takabatake
authors.forename: S
authors.initials: S
authors.lastname: Tagaki
authors.forename: K
authors.initials: K
authors.lastname: Sekine
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids
chemical_list: D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D000077146:Irinotecan; D016190:Carboplatin; C072115:nartograstim; D017239:Paclitaxel; D002166:Camptothecin