Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy

Summary

The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.

Timeline

Start

1994-09

Primary completion

—

Completion

2000-07

Publications

• Background Rowinsky EK, Donehower RC. The clinical pharmacology of paclitaxel (Taxol). Semin Oncol. 1993 Aug;20(4 Suppl 3):16-25.
• Background Huizing MT, Keung AC, Rosing H, van der Kuij V, ten Bokkel Huinink WW, Mandjes IM, Dubbelman AC, Pinedo HM, Beijnen JH. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol. 1993 Nov;11(11):2127-35. doi: 10.1200/JCO.1993.11.11.2127.
• Background Kohn EC, Sarosy G, Bicher A, Link C, Christian M, Steinberg SM, Rothenberg M, Adamo DO, Davis P, Ognibene FP, et al. Dose-intense taxol: high response rate in patients with platinum-resistant recurrent ovarian cancer. J Natl Cancer Inst. 1994 Jan 5;86(1):18-24. doi: 10.1093/jnci/86.1.18.

Drugs

Indications