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

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 2

Conditions: Kidney Cancer

Treatments: Drug: gefitinib

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00014183

NCI-1639

CDR0000068512

MSGCC-0044

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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