ZD 1839 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00012337
First received: March 3, 2001
Last updated: June 20, 2013
Last verified: March 2002

March 3, 2001
June 20, 2013
January 2001
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Complete list of historical versions of study NCT00012337 on ClinicalTrials.gov Archive Site
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ZD 1839 in Treating Patients With Metastatic Kidney Cancer
A Trial of ZD1839 (Iressa) in Patients With Advanced Renal Cell Carcinoma

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Kidney Cancer
Drug: gefitinib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2004
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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

Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00012337
CDR0000068507, MSKCC-00125, NCI-1373
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Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
March 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP