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ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00014183
Recruitment Status : Completed
First Posted : January 1, 2004
Last Update Posted : September 24, 2009
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland

Brief Summary:

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of kidney cancer.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: gefitinib Phase 2

Detailed Description:


  • Determine the response rate in patients with progressive stage IV or recurrent renal cell cancer treated with ZD 1839.
  • Determine the median time to objective progression in these patients receiving this drug.
  • Determine the toxic effects of this drug in this patient population.
  • Determine if epidermal growth factor receptor expression in tumor tissue correlates with response and survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral ZD 1839 daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 11-23 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
Study Start Date : January 2001
Primary Completion Date : May 2002
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery
  • Evidence of disease progression
  • Measurable disease

    • At least 20 mm with conventional techniques OR
    • At least 10 mm with spiral CT scan
  • No brain metastases
  • Malignant tissue available



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 2 months


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)


  • Creatinine no greater than 1.5 times ULN


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • No prior allergy to compounds of similar chemical or biologic composition to ZD 1839
  • No ongoing or active infection
  • No other uncontrolled illness or psychiatric condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens
  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunotherapy


  • No more than 1 prior chemotherapy regimen
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics


  • No prior therapy for metastatic disease
  • No other concurrent investigational agents
  • No concurrent oral retinoids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014183

United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
Study Chair: Nancy A. Dawson, MD University of Maryland Greenebaum Cancer Center

Responsible Party: UM Greenebaum Cancer Center
ClinicalTrials.gov Identifier: NCT00014183     History of Changes
Other Study ID Numbers: CDR0000068512
First Posted: January 1, 2004    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by University of Maryland:
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action