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


Authors: Molina, A. M.; Feldman, D. R.; Ginsberg, M. S.; Kroog, G.; Tickoo, S. K.; Jia, X.; Georges, M.; Patil, S.; Baum, M. S.; Reuter, V. E.; Motzer, R. J.
Article Title: Phase II trial of sunitinib in patients with metastatic non-clear cell renal cell carcinoma
Abstract: 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 nonclear 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. © Springer Science+Business Media, LLC 2010.
Keywords: adult; cancer chemotherapy; cancer survival; clinical article; controlled study; treatment response; aged; drug tolerability; fatigue; neutropenia; sunitinib; cancer growth; diarrhea; drug efficacy; drug safety; hypertension; side effect; outcome assessment; metastasis; progression free survival; multiple cycle treatment; phase 2 clinical trial; anemia; leukopenia; mucosa inflammation; thrombocytopenia; vomiting; clinical assessment; kidney carcinoma; lymphocytopenia; rash; hyperkalemia; thrombosis; clinical evaluation; hand foot syndrome; phase ii trial; papillary renal cell carcinoma; non-clear cell renal cell carcinoma
Journal Title: Investigational New Drugs
Volume: 30
Issue: 1
ISSN: 0167-6997
Publisher: Springer  
Date Published: 2012-02-01
Start Page: 335
End Page: 340
Language: English
DOI: 10.1007/s10637-010-9491-6
PROVIDER: scopus
PMCID: PMC3257373
PUBMED: 20711632
DOI/URL:
Notes: --- - "Export Date: 1 March 2012" - "CODEN: INNDD" - "Source: Scopus"
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MSK Authors
  1. Sujata Patil
    386 Patil
  2. Robert Motzer
    769 Motzer
  3. Michael S Baum
    20 Baum
  4. Michelle S Ginsberg
    159 Ginsberg
  5. Xiaoyu Jia
    44 Jia
  6. Satish K Tickoo
    370 Tickoo
  7. Glenn Kroog
    4 Kroog
  8. Darren Richard Feldman
    172 Feldman
  9. Ana Maria Luisa Molina
    45 Molina
  10. Victor Reuter
    922 Reuter