Phase II trial of ZD1839 (IRESSA™) in patients with advanced renal cell carcinoma Journal Article

  


Authors: Drucker, B.; Bacik, J.; Ginsberg, M.; Marion, S.; Russo, P.; Mazumdar, M.; Motzer, R.
Article Title: Phase II trial of ZD1839 (IRESSA™) in patients with advanced renal cell carcinoma
Abstract: Eighteen patients with advanced renal cell carcinoma (RCC) were treated on a phase II trial with ZD1839 (IRESSA). Treatment efficacy was determined using the endpoint of improvement in time to progression (TTP) compared to TTP in patients who received interferon-α therapy. The Memorial Sloan Kettering Cancer Center database of renal cell patients shows that patients receiving therapy with interferon-α had a median TTP of 4.7 months, with 40% of patients having disease progression at 4 months. To show efficacy in this trial, 60% of evaluable patients would have to remain progression free at 4 months. Treatment with ZD1839 did not result in any complete or partial responses, and 13 patients (81%) had progression of disease within 4 months of start of therapy. At the dose and schedule used in this trial, the lack of antitumor activity associated with ZD1839 does not support further study in patients with metastatic RCC.
Keywords: adult; clinical article; treatment outcome; aged; middle aged; survival rate; thalidomide; clinical trial; fatigue; cancer growth; diarrhea; drug efficacy; antineoplastic agents; alpha interferon; interleukin 2; metastasis; liver toxicity; phase 2 clinical trial; blood toxicity; neuropathy; antineoplastic activity; renal cell carcinoma; kidney carcinoma; kidney neoplasms; dyspnea; hyperglycemia; rash; carcinoma, renal cell; gefitinib; eye disease; dry eye; quinazolines; alopecia; phase ii trial; zd1839; blepharitis; humans; human; male; female; priority journal; article
Journal Title: Investigational New Drugs
Volume: 21
Issue: 3
ISSN: 0167-6997
Publisher: Springer  
Date Published: 2003-08-01
Start Page: 341
End Page: 345
Language: English
DOI: 10.1023/a:1025472712456
PUBMED: 14578682
PROVIDER: scopus
DOI/URL:

http://www.scopus.com/inward/record.url?eid=2-s2.0-0345714775&partnerID=40&md5=cd4ebcc803a2226e8817b4cc619c1dc9
Notes: Export Date: 12 September 2014 -- Source: Scopus
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MSK Authors
  1. Paul Russo
    581 Russo
  2. Robert Motzer
    1243 Motzer
  3. Michelle S Ginsberg
    235 Ginsberg
  4. Madhu Mazumdar
    127 Mazumdar
  5. Beverly J Drucker
    7 Drucker
  6. Jennifer M Bacik
    46 Bacik
  7. Stephanie Marion
    8 Marion
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