ZD 1839 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: March 3, 2001
Last updated: June 20, 2013
Last verified: March 2002

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.

Condition Intervention Phase
Kidney Cancer
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Trial of ZD1839 (Iressa) in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Study Completion Date: March 2004
Detailed Description:

OBJECTIVES: I. Determine the efficacy of ZD 1839 in patients with metastatic renal cell cancer. II. Determine the time to disease progression in patients treated with this drug. III. Determine the safety of this drug in these patients.

OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 1 year.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00012337

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00012337     History of Changes
Other Study ID Numbers: CDR0000068507  MSKCC-00125  NCI-1373 
Study First Received: March 3, 2001
Last Updated: June 20, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on May 24, 2016