Cancer Chemotherapy and Pharmacology

, Volume 70, Issue 1, pp 121–128

A phase I study of temsirolimus plus carboplatin plus paclitaxel for patients with recurrent or metastatic (R/M) head and neck squamous cell cancer (HNSCC)

  • Matthew G. Fury
  • Eric Sherman
  • Alan Ho
  • Nora Katabi
  • Camelia Sima
  • Katherine W. Kelly
  • Oby Nwankwo
  • Sofia Haque
  • David G. Pfister
Original Article

DOI: 10.1007/s00280-012-1894-y

Cite this article as:
Fury, M.G., Sherman, E., Ho, A. et al. Cancer Chemother Pharmacol (2012) 70: 121. doi:10.1007/s00280-012-1894-y

Abstract

Purpose

The mammalian target of rapamycin complex 1 (mTORC1) is aberrantly activated in many head and neck squamous cell carcinomas (HNSCCs). This phase I study combines the mTORC1 inhibitor temsirolimus with carboplatin and paclitaxel.

Methods

This was a single institution phase I study for patients with R/M HNSCC with a standard 3 + 3 design. Three doses of temsirolimus were planned: 15, 20, and 25 mg. Due to excessive toxicity with the original study regimen, the protocol was amended to carboplatin AUC 1.5, paclitaxel 80 mg/m2, and temsirolimus (according to dose escalation plan), all on days 1 and 8 of a 21-day cycle.

Results

18 patients (14 male, 4 female) enrolled, with median age 56 years (range 33–78). The most common toxicities were anemia, leukopenia, thrombocytopenia, and hyperglycemia. Among all patients treated, the confirmed objective partial response (cPR) rate was 22 %. DLT was not exceeded among 6 patients treated at dose level 3 of the revised protocol, and 4 of 6 subjects treated at this dose level had cPRs.

Conclusion

The phase II recommended regimen is temsirolimus 25 mg, carboplatin AUC 1.5, and paclitaxel 80 mg/m2, all on days 1 and 8 of a 21-day cycle. A phase II study of this regimen in R/M HNSCC is ongoing.

Keywords

Head and neck Squamous Phase I Temsirolimus Carboplatin Paclitaxel 

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Matthew G. Fury
    • 1
    • 5
  • Eric Sherman
    • 1
    • 5
  • Alan Ho
    • 1
    • 5
  • Nora Katabi
    • 2
  • Camelia Sima
    • 3
  • Katherine W. Kelly
    • 1
  • Oby Nwankwo
    • 1
  • Sofia Haque
    • 4
  • David G. Pfister
    • 1
    • 5
  1. 1.Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  2. 2.Department of PathologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  3. 3.Department of Epidemiology and BiostatisticsMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.Department of RadiologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  5. 5.Department of MedicineWeill Cornell Medical CollegeNew YorkUSA

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