Seminars in oncology
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Seminars in oncology · Dec 1995
Clinical TrialPaclitaxel combined with carboplatin in the first-line treatment of advanced ovarian cancer.
In a phase I study to determine the maximum tolerated dose of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given as a 3-hour infusion in combination with carboplatin administered every 21 days to women with advanced ovarian cancer, paclitaxel doses were escalated as follows: level 1, 135 mg/m2; level 2, 160 mg/m2; level 3, 185 mg/m2; and level 4,210 mg/m2. The fixed dose of carboplatin at levels 1 through 4 was given to achieve an area under the concentration-time curve (AUC) of 5 using the Calvert formula. In levels 5 and 6 the carboplatin dose was targeted at AUCs of 6 and 7.5, respectively, combined with a fixed paclitaxel dose of 185 mg/m2. ⋯ No patient had disease progression. We conclude that the combination of paclitaxel 185 mg/m2 administered as a 3-hour infusion followed immediately by a 1-hour infusion of carboplatin at an AUC of 6 can be administered safely in a 21-day schedule in the outpatient setting. The recommended dose for phase III studies is paclitaxel 185 mg/m2 and carboplatin AUC 6.
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Seminars in oncology · Dec 1995
Clinical TrialPaclitaxel and simultaneous radiation in the treatment of stage III A/B non-small cell lung cancer.
In a clinical phase II trial, radiotherapy and escalating doses of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) were given concurrently to patients with stage IIIA/B non-small cell lung cancer. Radiotherapy was given in daily doses of 2 Gy, 5 days a week, in weeks 1 to 3 and 6 to 8 for a total dose of 56 Gy. Paclitaxel was given in 3-hour infusions on day 1, also in weeks 1 to 3 and 6 to 8. ⋯ Four patients had a major response with nearly complete disappearance of radiologic tumor signs, five patients had a partial remission, and three patients experienced a minor response. Thus, the overall response rate was 75%. In summary, the maximum tolerated dose of paclitaxel has not yet been achieved, the occurrence of pulmonary infections represents the major clinical toxicity, and the extremely high response rate merits further clinical evaluation of this regimen.