Phase I study of Carzelesin (U-80,244) given (4-weekly) by intravenous bolus schedule
1999

Study of Carzelesin for Advanced Solid Tumors

Sample size: 51 publication Evidence: moderate

Author Information

Author(s): Awada A, Punt C J A, Piccart M J, Tellingen O Van, Manen L Van, Kerger J, Groot Y, Wanders J, Verweij J, Wagener D J Th

Primary Institution: Institut Jules Bordet

Hypothesis

Carzelesin can be safely administered to patients with advanced solid tumors and its pharmacokinetics can be established.

Conclusion

Carzelesin has a maximum tolerated dose of 300 μg m−2 and shows linear pharmacokinetics, but cumulative haematological toxicity limits its use in multiple courses.

Supporting Evidence

  • Carzelesin was administered to 51 patients with advanced solid tumors.
  • The maximum tolerated dose for a single course was found to be 300 μg m−2.
  • Cumulative haematological toxicity limited the delivery of intended dose intensity in multiple courses.

Takeaway

This study tested a new cancer drug called Carzelesin on patients, finding that while it can help, it can also cause some serious side effects.

Methodology

Patients received Carzelesin as a 10 min IV infusion every four weeks at various dose levels.

Limitations

The study was limited by the cumulative haematological toxicity experienced by patients receiving multiple courses.

Participant Demographics

Patients had advanced solid tumors.

Digital Object Identifier (DOI)

10.1038/sj.bjc.6690232

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