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Clinical Trials |
Departments of Breast Medical Oncology [N. K. I., R. L. T., E. R., G. N. H.], Melanoma/Sarcoma [S. L., S. E. R., A. B., J. A. E.], and Ophthalmology [B. E.], The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, and American Bioscience, Inc., Santa Monica, California 90403 [N. D., P. S-S.]
Purpose: ABI-007 is a novel Cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel. The absence of Cremophor EL may permit ABI-007 to be administered without the premedications used routinely for the prevention of hypersensitivity reactions. Furthermore, this novel formulation permits a higher paclitaxel concentration in solution and, thus, a decreased infusion volume and time. This Phase I study examines the toxicity profile, maximum tolerated dose (MTD), and pharmacokinetics of ABI-007.
Experimental Design: ABI-007 was administered in the outpatient setting, as a 30-min infusion without premedications. Doses of ABI-007 ranged from 135 (level 0) to 375 mg/m2 (level 3). Sixteen patients participated in pharmacokinetic studies.
Results: Nineteen patients were treated. No acute hypersensitivity reactions were observed during the infusion period. Hematological toxicity was mild and not cumulative. Dose-limiting toxicity, which occurred in 3 of 6 patients treated at level 3 (375 mg/m2), consisted of sensory neuropathy (3 patients), stomatitis (2 patients), and superficial keratopathy (2 patients). The MTD was thus determined to be 300 mg/m2 (level 2). Pharmacokinetic analyses revealed paclitaxel Cmax and area under the curveinf values to increase linearly over the ABI-007 dose range of 135–300 mg/m2. Cmax and area under the curveinf values for individual patients correlated well with toxicity.
Conclusions: ABI-007 offers several features of clinical interest, including rapid infusion rate, absence of requirement for premedication, and a high paclitaxel MTD. Our results provide support for Phase II trials to determine the antitumor activity of this drug.
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