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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
Information provided by:
University of Maryland

April 10, 2001
January 1, 2004
September 24, 2009
January 2001
May 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00014183 on ClinicalTrials.gov Archive Site
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ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Kidney Cancer
Drug: gefitinib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2005
May 2002   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 2 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics

Other:

  • No prior therapy for metastatic disease
  • No other concurrent investigational agents
  • No concurrent oral retinoids
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00014183
CDR0000068512
MSGCC-0044
NCI-1639
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UM Greenebaum Cancer Center
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
University of Maryland
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP