Docetaxel (Taxotere) and vinorelbine in the treatment of advanced non-small cell lung cancer: Preliminary results of a phase I/II trial Journal Article


Author: Miller, V. A.
Article Title: Docetaxel (Taxotere) and vinorelbine in the treatment of advanced non-small cell lung cancer: Preliminary results of a phase I/II trial
Abstract: We undertook a phase I/II study of the combination of docetaxel (Taxotere; Rhone-Poulenc Rorer, Antony, France) and vinorelbine in the treatment of unresectable or metastatic non-small cell lung cancer (NSCLC). Nineteen patients with unresectable NSCLC received a combination of docetaxel 50 mg/m2 and vinorelbine 15 to 45 mg/m2 every 2 weeks. All patients received prophylactic granulocyte-colony stimulating factor 5 μg/kg/d and corticosteroids. The incidence of hematologic toxicity with this dosing schedule was low; only 2.5% of treatment cycles were complicated by febrile neutropenia. The maximum tolerated dose has not been reached. It is concluded that using this schedule, a combination of docetaxel and vinorelbine can be administered in combination, together with granulocyte-colony stimulating factor, with a low risk of associated hematologic toxicity. Further dose escalation is needed to determine the maximum tolerated dose of the combination. A partial response was observed in five patients (26%; 95% confidence interval, 15% to 57%), and nine (47%) patients showed stable disease. Based on these preliminary results, the combination of these two drugs appears to have antitumor activity against NSCLC and warrants continued study.
Keywords: adult; clinical article; aged; middle aged; clinical trial; drug tolerability; neutropenia; review; diarrhea; dose response; gastrointestinal hemorrhage; paclitaxel; antineoplastic agent; phase 2 clinical trial; blood toxicity; lung non small cell cancer; mucosa inflammation; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; antineoplastic agents, phytogenic; antineoplastic activity; vinblastine; docetaxel; hyperglycemia; pneumonia; lung tumor; vein thrombosis; drug derivative; taxoids; bacteremia; phase 1 clinical trial; corticosteroid; navelbine; recombinant granulocyte colony stimulating factor; taxoid; chondritis; humans; human; male; female; priority journal; article
Journal Title: Seminars in Oncology
Volume: 24
Issue: 4 Suppl. 14
ISSN: 0093-7754
Publisher: Elsevier Inc.  
Date Published: 1997-08-01
Start Page: S14-15
End Page: S14-17
Language: English
PUBMED: 9335518
PROVIDER: scopus
DOI/URL:
Notes: Review -- Export Date: 17 March 2017 -- Source: Scopus
Citation Impact
MSK Authors
  1. Vincent Miller
    270 Miller