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[Early phase II study of BMS-181339 (paclitaxel) in patients with non-small cell lung cancer. BMS-181339 Non-Small Cell Lung Cancer Study Group].

Abstract
We conducted a multi-institutional (11 facilities), early phase II study of BMS-181339 (paclitaxel), a novel anti-cancer drug, for non-small cell lung cancer (NSCLC). The 150 mg/m2 dose of paclitaxel was given by intravenous infusion over 24 hours every three weeks. When fifteen patients were accumulated, the interim review revealed that three of 15 eligible patients had a partial response for a response rate of 20%. The most common toxic effects were grade 3 or 4 leukopenia seen in 73.3% (11/15), and grade 4 neutropenia in 93.3% (14/15). One patient with neutropenia had suspected septic shock, which could be managed by G-CSF and antibiotics. No serious hypersensitivity reaction was seen with premedication of anti-allergic drugs, although mild allergic reactions such as skin rash and flush, were observed in 20.0% (3/15). Other adverse reactions, including alopecia, fever, arthralgia, myalgia and peripheral neuropathy, were mild in most cases. We conclude that it is relevant to proceed to a late phase II study for NSCLC.
AuthorsS Yoneda, Y Nishiwaki, H Niitani, Y Kurita, Y Ariyoshi, H Ikegami, K Furuse, M Fukuoka, I Kimura, N Hara, N Saijo
JournalGan to kagaku ryoho. Cancer & chemotherapy (Gan To Kagaku Ryoho) Vol. 23 Issue 6 Pg. 695-701 (May 1996) ISSN: 0385-0684 [Print] Japan
PMID8645020 (Publication Type: Clinical Trial, Clinical Trial, Phase II, English Abstract, Journal Article, Multicenter Study)
Chemical References
  • Antineoplastic Agents, Phytogenic
  • BMS 181339
  • Taxoids
  • Paclitaxel
Topics
  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, therapeutic use)
  • Carcinoma, Non-Small-Cell Lung (drug therapy)
  • Drug Administration Schedule
  • Drug Hypersensitivity (etiology)
  • Female
  • Humans
  • Infusions, Intravenous
  • Japan
  • Leukopenia (chemically induced)
  • Lung Neoplasms (drug therapy)
  • Male
  • Middle Aged
  • Paclitaxel (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Remission Induction
  • Taxoids

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