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	Treatment or Intervention	Phase
Stage IV Renal Cell Cancer recurrent renal cell cancer	Procedure: protein tyrosine kinase inhibitor therapy  Procedure: enzyme inhibitor therapy  Drug: ZD 1839	Phase II

Further Study Details: 

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

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3
• 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

Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
      Veterans Affairs Medical Center - Baltimore, Baltimore,  Maryland,  21201,  United States

Study chairs or principal investigators

Nancy Ann Dawson,  Study Chair,  University of Maryland Greenebaum Cancer Center   

Study ID Numbers:  CDR0000068512; MSGCC-0044; NCI-1639
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014183
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08