Phase I clinical trial of weekly combined paclitaxel plus docetaxel in patients with solid tumors

✍ Scribed by Jacob Lokich

• Publisher: John Wiley and Sons
• Year: 2000
• Tongue: English
• Weight: 70 KB
• Volume: 89
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(20001201)89:11<2309::aid-cncr20>3.0.co;2-8

✦ Synopsis

A Phase I and feasibility study of combined docetaxel (D) plus paclitaxel (P) was undertaken to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for each analogue delivered concomitantly on a weekly schedule.

METHODS.

Patients were accrued in 3-6 patient cohorts to P administered over a course of 45-60 minutes followed by D infused over a course of 30 minutes for 4 consecutive weeks with the cycles repeated at 6 weeks. The MTD was defined as the dose of each agent administered with at least Grade 3 (according to National Cancer Institute standard criteria) hematologic toxicity in 50% of the patients but without Grade 4 toxicity.

RESULTS.

Twenty patients received D plus P weekly for 4 weeks at 4 dose levels. At the highest P dose (80 mg/m 2 ; total dose per cycle, 320 mg/m 2 ) 2 of 6 patients received treatment for 4 consecutive weeks but 5 of 6 patients developed hematologic and/or nonhematologic (skin) DLTs. The recommended treatment doses for this combined taxane regimen is D, 35 mg/m 2 /week, plus P, 65 mg/m 2 /week, for 4 weeks. An unusual cutaneous syndrome was observed in four patients that was manifested as erythema and blistering on the dorsum of the hands.