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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001387
Enrollment
25
Registered
2002-12-10
Start date
1994-09-30
Completion date
2000-07-31
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Paclitaxel, Pediatric, Pharmacokinetics, Phase I, Toxicity

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.

Interventions

DRUGpaclitaxel

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed cancer (including leukemia) that is: Refractory to standard therapy (objective disease progression required) OR For which no standard therapy exists and patient is ineligible for potentially curative surgery. PRIOR/CONCURRENT THERAPY: Recovery from the toxic effects of prior therapy required. Biologic Therapy: Not specified. Chemotherapy: No prior taxanes. At least 3 weeks since myelosuppressive therapy (6 weeks since nitrosourea). Endocrine Therapy: Not specified. Radiotherapy: Prior extensive craniospinal or pelvic irradiation allowed. Surgery: Ineligible for potential curative surgery. Other: Prior bone marrow transplant allowed. PATIENT CHARACTERISTICS: Age: Over 1 to 21; Performance status: ECOG 0-2; Life expectancy: At least 8 weeks. Hematopoietic: (except with leukemia, bone marrow involvement, history of bone marrow transplantation, or extensive prior radiotherapy). Absolute granulocyte count at least 1,500/mm(3); Platelet count at least 100,000/mm(3); Hemoglobin at least 8.0 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL OR; Creatinine clearance at least 60 mL/min per square meter. OTHER: No concurrent anticonvulsant therapy. No grade 2 or worse neuropathy. No significant systemic illness (e.g., infection) that could compromise drug excretion or confuse assessment of toxicity. Not pregnant or nursing.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026