Kidney Cancer Clinical Trial
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21201, United States
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