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

National Cancer Institute (NCI)1 site in 1 country25 target enrollmentSeptember 1994

ConditionsNeoplasms

Drugspaclitaxel

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Neoplasms
Sponsor: National Cancer Institute (NCI)
Enrollment: 25
Locations: 1
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Paclitaxel is an active antitumor agent that has demonstrated a broad range of activity in preclinical and clinical studies. The optimal dose and schedule has not yet been determined in either adults or children. 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. In addition, the pharmacokinetics of paclitaxel given in this way will be studied and both model-dependent and model-independent parameters will be determined.

Registry

clinicaltrials.gov

Start Date

September 1994

End Date

July 2000

Last Updated

18 years ago

Study Type

Interventional

Sex

All