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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: National Cancer Institute (NCI); University of Maryland Greenebaum Cancer Center
• Treatments: Gefitinib

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