Phase I trial and pharmacological study of a 3-hour paclitaxel infusion in children with refractory solid tumours: a SFOP study
2001

Study of Paclitaxel Infusion in Children with Tumors

Sample size: 17 publication Evidence: moderate

Author Information

Author(s): Doz F, Gentet J C, Pein F, Frappaz D, Chastagner P, Moretti S, Vassal G, Arditti J, Tellingen O Van, Iliadis A, Catalin J

Primary Institution: Departement d'Oncologie Pédiatrique, Institut Curie

Hypothesis

Can a 3-hour infusion of paclitaxel be safely administered to children with refractory solid tumors without increasing toxicity?

Conclusion

The study found that while no dose-limiting haematological toxicity was observed, the 3-hour paclitaxel infusion schedule is not recommended due to acute neurological toxicity.

Supporting Evidence

  • 20 courses were studied in 17 patients.
  • 4 dosage levels of paclitaxel were investigated.
  • No dose-limiting haematological toxicity was observed.
  • Severe acute neurological and allergic toxicity was encountered.
  • One treatment-related death occurred at the highest dosage.

Takeaway

Doctors tested a new way to give a cancer medicine to kids, but it caused some serious side effects, so they decided it wasn't safe.

Methodology

Paclitaxel was administered as a 3-hour infusion after premedication, and pharmacokinetic analysis was performed during the first course.

Limitations

The study encountered severe acute neurological and allergic toxicity, leading to a treatment-related death.

Participant Demographics

Patients aged 6 months to 20 years with refractory malignant solid tumors.

Digital Object Identifier (DOI)

10.1054/bjoc.2000.1637

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