Investigational New Drugs

, Volume 30, Issue 1, pp 335–340

Phase II trial of sunitinib in patients with metastatic non-clear cell renal cell carcinoma

  • Ana M. Molina
  • Darren R. Feldman
  • Michelle S. Ginsberg
  • Glenn Kroog
  • Satish K. Tickoo
  • Xiaoyu Jia
  • Murielle Georges
  • Sujata Patil
  • Michael S. Baum
  • Victor E. Reuter
  • Robert J. Motzer
PHASE II STUDIES

DOI: 10.1007/s10637-010-9491-6

Cite this article as:
Molina, A.M., Feldman, D.R., Ginsberg, M.S. et al. Invest New Drugs (2012) 30: 335. doi:10.1007/s10637-010-9491-6

Summary

Sunitinib is associated with a robust objective response rate in patients with metastatic clear cell renal cell carcinoma (RCC). The primary objective of this phase II clinical trial was to assess the overall response rate for sunitinib in patients with papillary metastatic RCC as well as other non-clear cell histologies. A Simon 2-stage design was used to determine the number of papillary metastatic RCC patients for enrollment, and allowed for descriptive response data for other non-clear cell histologies. Twenty-three patients were enrolled, including 8 with papillary renal cell carcinoma (RCC) and the remainder with other non-clear cell histologies (unclassified in 5 patients). All patients received 50 mg of oral sunitinib in cycles of 4 weeks followed by 2 weeks of rest (4/2). The trial was stopped early because of slow accrual; no responses were observed in the 8 patients with papillary RCC. In the 22 evaluable patients, best response to sunitinib included a partial response in 1 patient with unclassified RCC, stable disease in 15, and progression in 6. The median progression-free survival was 5.5 months (95% CI, 2.5–7.1) in all 23 patients, and 5.6 months for the 8 papillary patients (95% CI, 1.4–7.1). The robust objective responses sunitinib had produced in clear cell RCC could not be demonstrated in this study comprised of patients with non-clear cell histologies.

Keywords

Papillary renal cell carcinomaNon-clear cell renal cell carcinomaSunitinibPhase II trial

Abbreviations

mRCC

Metastatic renal cell carcinoma

RCC

Renal cell carcinoma

HLRCC

Hereditary leiomyomatosis and renal cell cancer

CTCAE

Common toxicity criteria for adverse events

RECIST

Response evaluation criteria in solid tumors

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Ana M. Molina
    • 1
    • 6
  • Darren R. Feldman
    • 1
    • 6
  • Michelle S. Ginsberg
    • 2
  • Glenn Kroog
    • 1
    • 6
  • Satish K. Tickoo
    • 3
  • Xiaoyu Jia
    • 4
  • Murielle Georges
    • 1
  • Sujata Patil
    • 4
  • Michael S. Baum
    • 5
  • Victor E. Reuter
    • 3
  • Robert J. Motzer
    • 1
    • 6
  1. 1.Genitourinary Oncology Service, Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  2. 2.Department of Medical ImagingMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  3. 3.Department of PathologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.Department of Biostatistics and EpidemiologyMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  5. 5.Cardiology Service, Department of MedicineMemorial Sloan-Kettering Cancer CenterNew YorkUSA
  6. 6.Department of MedicineWeil Medical College of Cornell UniversityNew YorkUSA