Phase I trial of docetaxel and vinorelbine in patients with advanced nonsmall cell lung carcinoma Journal Article
| Authors: | Miller, V. A.; Ng, K. K.; Krug, L. M.; Perez, W.; Pizzo, B.; Heelan, R. T.; Kris, M. G. |
| Article Title: | Phase I trial of docetaxel and vinorelbine in patients with advanced nonsmall cell lung carcinoma |
| Abstract: | BACKGROUND. With preclinical evidence of synergy, this dose-finding trial examining the combination of docetaxel and vinorelbine given with prophylactic filgrastim for the treatment of patients with nonsmall cell lung carcinoma was undertaken. METHODS. Twenty-seven patients with advanced nonsmall cell lung carcinoma received vinorelbine as an intravenous push immediately followed by docetaxel as a 1-hour intravenous infusion once every 2 weeks at 1 of 7 different close levels. Vinorelbine was escalated from 15 mg/m2 (Level I) to 45 mg/m2 (Level VII) and docetaxel was increased from 50 mg/m2 (Level I) to 60 mg/m2 (Level VII). Prophylactic corticosteroids and filgrastim were employed prospectively. RESULTS. After completion of dose Level VII, accrual was terminated because Phase II close intensity of both agents had been reached and further escalation was believed to be unsafe. At dose Level VII, one episode of first-cycle febrile neutropenia and a death after three treatment cycles due to Haemophilus influenzae sepsis (Grade 5 toxicity according to the Common Toxicity Criteria of the National Cancer Institute) without neutropenia were noted. In all, 209 treatment cycles were administered and febrile neutropenia was observed in only 4 of these treatments (1.9%). Bacteremia occurred in three patients (four episodes) in the absence of neutropenia. Symptomatic onycholysis was observed in three patients. Clinically significant peripheral neuropathy and fluid retention were rare. Confirmed partial responses were noted in 10 patients for a response rate of 37% (95% confidence interval, 20-57%). CONCLUSIONS. Docetaxel at a dose of 60 mg/m2 and vinorelbine at a dose of 45 mg/m2, both given every 2 weeks, can be combined safely to achieve Phase II dose intensity of both agents. An ongoing Phase II trial will define the activity of this treatment combination. (C) 2000 American Cancer Society. |
| Keywords: | adult; clinical article; aged; middle aged; clinical trial; advanced cancer; cancer combination chemotherapy; diarrhea; dose response; drug potentiation; paclitaxel; chemotherapy; anemia; lung non small cell cancer; nausea; vomiting; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; myalgia; peripheral neuropathy; antineoplastic agents, phytogenic; vinblastine; docetaxel; arthralgia; febrile neutropenia; sepsis; taxoids; bacteremia; phase 1 clinical trial; corticosteroid; navelbine; recombinant granulocyte colony stimulating factor; alopecia; nonsmall cell lung carcinoma; filgrastim; onycholysis; vinorelbine; humans; human; male; female; priority journal; article |
| Journal Title: | Cancer |
| Volume: | 88 |
| Issue: | 5 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2000-03-01 |
| Start Page: | 1045 |
| End Page: | 1050 |
| Language: | English |
| DOI: | 10.1002/(sici)1097-0142(20000301)88:5<1045::aid-cncr14>3.0.co;2-j |
| PUBMED: | 10699893 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 18 November 2015 -- Source: Scopus |
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