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

Phase 1

Completed

• Conditions: Neoplasms

• Registration Number: NCT00001387
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 1994-09
• Status Verified: 1999-08
• Study First Submitted: 1999-11-03
• Study Completion: 2000-07
• Study First Submitted QC: 2002-12-09
• Study First Posted: 2002-12-10
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Cancer Institute (NCI); 🇺🇸 Bethesda, Maryland, United States