Phase I/II trial of gemcitabine plus docetaxel in advanced non small cell lung cancer (NSCLC).
BACKGROUND
The poor prognosis of non small cell lung cancer (NSCLC), as well as the significant toxicity from many conventional cytotoxic regimens warrants the investigation of combinations of new active agents for treatment. This is a phase I-II (dose-finding, efficacy, and toxicity) study of docetaxel + gemcitabine in patients with stage IIIB-IV NSCLC without prior systemic therapy. PATIENTS were treated in cohorts of 3 with alternating increasing doses of docetaxel and gemcitabine at each level.


METHODS
Fifty patients were entered, of which 49 were eligible including 28 males and 21 females; 15 stage IIIB and 34 stage IV; median age 57 yrs (35-74).


RESULTS
The Maximum Tolerated Dose (MTD) was docetaxel 60 mg/m(2) day 1 and gemcitabine 750 mg/m(2) d1 & 8, every 21 days. The overall response rate is 20%. Eight patients are not formally assessable for response due to early discontinuation or loss to follow-up and are considered to have progressive disease. The median time to progression (TTP) is 3.5 months (1-25), with 11 pts with at least 7 months TTP. There were 10 pts (20%) with a partial response (PR); 18 (37%) maintained stable disease; 21 (43%) had progressive disease (PD) or were not assessable.


RESULTS
Forty-nine patients are evaluable for assessment for toxicity: Grade (Gr) 3/4 toxicity was documented thus: 14 with neutropenia, 1 with anemia, 1 with nausea, 2 liver function, 2 dyspnea, 2 fatigue, 1 allergy, 1 neurologic.


CONCLUSIONS
This regimen is well tolerated and results in phase I-II testing in this patient population warrant further consideration of the study of docetaxel + gemcitabine for advanced NSCLC.
Israel
Valerie
V
University of Southern California-Kenneth Norris Jr. Comprehensive Cancer Center and California Cancer Medical Center, Los Angeles, CA 90033, USA.
Tagawa
Scott T
ST
Snyder
Terry
T
Jeffers
Susan
S
Raghavan
Derek
D
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D015331:Cohort Studies; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine