Overview

ZD 1839 in Treating Patients With Metastatic Kidney Cancer

Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD 1839 may interfere with the growth factors and cause tumor cells to die. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have metastatic kidney cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Gefitinib
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma
Bidimensionally measurable disease Bone metastasis as only site must have at least 1
bidimensionally measurable tissue mass by CT or MRI (e.g., expansile lesion) Radiologic
evidence of disease progression or symptoms related to disease No brain metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: More than 3 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 less than
1.5 mg/dL ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine
no greater than 1.5 times ULN Other: No prior malignancy within the past 5 years unless
potentially curatively treated or deemed at low risk for recurrence Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
and recovered No more than 1 prior biologic regimen No other concurrent biologic therapy
Chemotherapy: At least 4 weeks since prior cytotoxic therapy and recovered No more than 1
prior cytotoxic regimen No concurrent cytotoxic therapy Endocrine therapy: At least 4 weeks
since prior hormonal therapy and recovered No more than 1 prior hormonal regimen No
concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No
concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery