Seminars in oncology
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Seminars in oncology · Dec 1995
Clinical Trial Controlled Clinical TrialA phase I/II trial of combination paclitaxel and carboplatin in advanced or metastatic non-small cell lung cancer: preliminary results of an ongoing study.
Because of paclitaxel's (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) high single-agent activity in non-small cell lung cancer we developed a study to determine the maximum tolerated dose and a dose suitable for outpatient phase II/III trials of paclitaxel combined with a fixed dose of carboplatin (area under the concentration-time curve of 6, Calvert formula). From October 1993 to November 1994, 41 patients were entered into this trial, including six at dose level I (paclitaxel 150 mg/m2), six at dose level 2 (paclitaxel 175 mg/m2), II at dose level 3 (paclitaxel 200 mg/m2), 13 at dose level 4 (paclitaxel 225 mg/m2), and five at dose level 5 (paclitaxel 250 mg/m2). Patient characteristics included 27 men and 14 women with a median age of 64 years (age range, 46 to 81 years). ⋯ The maximum tolerated dose was defined at the 250 mg/m2 dose level with three of five patients achieving grade 3 (severe toxicity. The 225 mg/m2 dose level appears to be well tolerated, but accrual at this dose level is ongoing. This appears to be a highly active regimen, with objective responses in 20 (two complete responses and 18 partial responses) of 32 patients with objectively measurable disease for an overall response rate of 62.5%.
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Seminars in oncology · Dec 1995
Comparative Study Clinical TrialChemotherapy of advanced inoperable non-small cell lung cancer with paclitaxel: a phase II trial.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has demonstrated significant antineoplastic activity against different tumor types, notably ovarian and breast carcinoma. Two phase II trials of 24-hour paclitaxel infusions in chemotherapy-naive patients with stage IIIB or IV non-small cell lung cancer (NSCLC) reported response rates of 21% and 24%. Leukopenia was dose limiting: as many as 62.5% of patients experienced grade 4 leukopenia. ⋯ Nausea and vomiting were infrequent, with 14% of patients experiencing grade 1 or 2 and only 2% experiencing grade 3 or 4. Paclitaxel is thus an active single agent in this patient population, with a 3-hour infusion proving comparably effective to a 24-hour infusion and superior in terms of the incidence of hematologic and nonhematologic toxicity. Further phase II studies with paclitaxel combined with other drugs active against NSCLC are indicated, and phase III studies comparing paclitaxel with standard chemotherapy remain to be completed.