Authors: | Johnson, E.; Lake, D.; Herndon, J. E. 2nd; Box, J. W.; Lynch, T. J.; Green, M. R. |
Article Title: | Phase II trial of vinorelbine plus doxorubicin in relapsed small-cell lung cancer: CALGB 9332 |
Abstract: | Small-cell lung cancer that progresses after initial response may still be sensitive to systemic treatment. This study assessed doxorubicin plus vinorelbine tartrate (Navelbine Injection) in patients who had no prior exposure to these agents. Treatment consisted of vinorelbine at 25 mg/m 2 on days 1 and 8 and doxorubicin at 50 mg/m 2 on day 1 of each 21-day cycle. The trial was stopped early because of excessive toxicity. The partial response rate was 26.7%. Toxicities included grade IV neutropenia in 73%, and febrile neutropenia and/or sepsis in 60%. Three patients died from sepsis during cycle 1. Performance status 2 was significantly associated with febrile neutropenia (p = 0.044). Although this regimen had some activity, the toxicity precluded further evaluation. |
Keywords: | adult; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; survival analysis; clinical trial; disease course; neutropenia; cancer recurrence; doxorubicin; cancer combination chemotherapy; side effect; controlled clinical trial; phase 2 clinical trial; neoplasm recurrence, local; antineoplastic combined chemotherapy protocols; lung neoplasms; antineoplastic activity; drug screening; vinblastine; febrile neutropenia; cause of death; lung small cell cancer; death; sepsis; navelbine; drug sensitivity; phase i trial; drug exposure; small-cell lung cancer; carcinoma, small cell; vinorelbine; humans; human; male; female; article |
Journal Title: | American Journal of Clinical Oncology |
Volume: | 27 |
Issue: | 1 |
ISSN: | 0277-3732 |
Publisher: | Lippincott Williams & Wilkins |
Date Published: | 2004-02-01 |
Start Page: | 19 |
End Page: | 23 |
Language: | English |
DOI: | 10.1097/01.coc.0000045850.98788.ED |
PROVIDER: | scopus |
PUBMED: | 14758128 |
DOI/URL: | |
Notes: | Am. J. Clin. Oncol. Cancer Clin. Trials -- Cited By (since 1996):5 -- Export Date: 16 June 2014 -- CODEN: AJCOD -- Source: Scopus |