Docetaxel followed by gemcitabine in the treatment of advanced non-small cell lung cancer: a phase I study.
OBJECTIVE
Based on the results of a preclinical study, a phase I trial was conducted to evaluate the feasibility of administering docetaxel followed by gemcitabine in non-small cell lung cancer patients.


METHODS
Sixteen patients with advanced non-small cell lung cancer (stages III B-IV) were treated on the 1st day with docetaxel and on the 8th day with gemcitabine. Treatment was repeated every three weeks for a maximum of six cycles. Five groups received docetaxel/gemcitabine (mg/ml): 50/800, 60/800, 60/900, 60/1,000, 70/1,000. All patients and 57 cycles were assessed for toxicity.


RESULTS
The most important side effects were grade IV neutropenia in 4 patients (2 at the 60/1000 level and 2 at the 70/1000 level) and grade III leukopenia and neutropenia without fever in 4 and 6 patients, respectively. Maximum tolerated dose was not reached.


CONCLUSIONS
The sequence docetaxel-gemcitabine appears well tolerated and easy to administer. For this reason, a phase II study is ongoing to fully assess its antitumor activity.
Frassineti
Giovanni Luca
GL
Department of Medical Oncology, Pierantoni Hospital, Forlì, Italy.
Ibrahim
Toni
T
Zoli
Wainer
W
Monti
Manuela
M
Ricotti
Luca
L
Nanni
Oriana
O
Amadori
Dino
D
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D043823:Taxoids; D016896:Treatment Outcome; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine