Safety and pharmacokinetics of everolimus and paclitaxel in cancer patients
Author Information
Author(s): Campone M, Levy V, Bourbouloux E, Berton Rigaud D, Bootle D, Dutreix C, Zoellner U, Shand N, Calvo F, Raymond E
Primary Institution: Centre René Gauducheau, Nantes, France
Hypothesis
This study assessed the safety and the pharmacokinetic interactions of everolimus and paclitaxel in patients with advanced malignancies.
Conclusion
Everolimus showed an acceptable safety profile at the dose of 30 mg when combined with weekly paclitaxel 80 mg/m², warranting further clinical investigation.
Supporting Evidence
- Everolimus was dose escalated from 15 to 30 mg and administered with paclitaxel 80 mg/m².
- Grade 3 neutropenia was observed in six patients, with two meeting criteria for dose-limiting toxicity.
- Tumour stabilisation was reported in 11 patients, with two patients experiencing stabilisation exceeding 6 months.
Takeaway
Doctors tested a new cancer treatment combining two drugs, everolimus and paclitaxel, and found it to be safe for patients.
Methodology
This was an open-label dose-escalation study where everolimus was given with paclitaxel to assess safety and pharmacokinetics.
Limitations
The study involved a small sample size and was limited to heavily pre-treated patients.
Participant Demographics
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Digital Object Identifier (DOI)
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