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ZD 1839 in Treating Patients With Metastatic Kidney Cancer



ZD 1839 in Treating Patients With Metastatic Kidney Cancer

For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Drugs such as ZD1839 may interfere with the growth factors and cause tumor cells to die. PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic kidney cancer.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertMotzer,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 


Additional Information:
Study ID Numbers:  CDR0000068507;  MSKCC-00125,NCI-1373
Study Start Date: January 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012337

Other Stage 4 Renal Cell Cancer Studies:
1. Magnetic-Resonance-Guided Radiofrequency Ablation in Treating Patients With Primary Kidney Cancer, Liver Metastases, or Other Solid Tumors

2. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

3. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer

4. Capecitabine and Gemcitabine in Treating Patients With Metastatic Kidney Cancer

5. High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

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