Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
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.
Detailed 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.
Interventions
DRUGgefitinib
Sponsors
National Cancer Institute (NCI)
University of Maryland Greenebaum Cancer Center
University of Maryland, Baltimore
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed