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Investigational New Drugs

, Volume 34, Issue 2, pp 231–235 | Cite as

A phase II study of cediranib, an oral VEGF inhibitor, in previously untreated patients with metastatic or recurrent malignant melanoma

  • Elaine McWhirter
  • Ian Quirt
  • Thomas Gajewski
  • Gregory Pond
  • Lisa Wang
  • June Hui
  • Amit Oza
PHASE II STUDIES
  • 176 Downloads

Summary

Purpose A two stage multi-institution Phase II study was undertaken by the Princess Margaret Hospital Consortium to evaluate the efficacy and toxicity of oral cediranib, an inhibitor of vascular endothelial growth factor receptors 1 and 2, in patients with previously untreated advanced malignant melanoma. Patients and Methods Between May 2006 and April 2008, 24 patients (median age 65 years) with advanced malignant melanoma were treated with oral cediranib. Cediranib was given on a continuous, oral once daily schedule of 45 mg, on a 28 day cycle. Results Of the 17 patients evaluable for response, there was stable disease in 8 patients, and progressive disease in 9 patients, with no objective responses seen. Only 2 patients had stable disease >/= 6 months, thus the study was terminated at the end of stage 1 accrual. The overall median survival was 9.9 months, and the median time to progression was 3.5 months. The most frequent non-hematologic adverse events were hypertension (78 %), fatigue (69 %), diarrhea (69 %) and anorexia and nausea (each 57 %). Conclusions Although 2 patients had stable disease at 6 months, the short median time to progression and lack of any objective responses indicate that single agent cediranib at this dose and schedule is not sufficiently active to warrant study continuation.

Keywords

Metastatic melanoma Cediranib Phase II trial First line therapy Vascular endothelial growth factor (VEGF) 

Notes

Acknowledgments

This study (PHL-038/NCI 7137) is conducted by the Princess Margaret Hospital Phase II Consortium with support from US National Cancer Institute Grant #HHSN261201100032C.

Compliance with ethical standards

Conflict of interest

The authors declare they have no conflict of interest.

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  • Elaine McWhirter
    • 1
  • Ian Quirt
    • 2
  • Thomas Gajewski
    • 3
  • Gregory Pond
    • 4
  • Lisa Wang
    • 2
  • June Hui
    • 2
  • Amit Oza
    • 2
  1. 1.Department of Medical OncologyJuravinski Cancer Centre, Hamilton Health Sciences CentreHamiltonCanada
  2. 2.Department of Medical Oncology, Princess Margaret Cancer CentreDrug Development ProgramTorontoCanada
  3. 3.University of Chicago Medical CentreChicagoUSA
  4. 4.Ontario Clinical Oncology GroupMcMaster UniversityHamiltonCanada

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