ZD 1839 in Treating Patients With Metastatic Kidney Cancer
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ClinicalTrials.gov Identifier: NCT00012337 |
Recruitment Status :
Completed
First Posted : March 17, 2004
Last Update Posted : June 24, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | March 3, 2001 | |||
First Posted Date ICMJE | March 17, 2004 | |||
Last Update Posted Date | June 24, 2013 | |||
Study Start Date ICMJE | January 2001 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | ZD 1839 in Treating Patients With Metastatic Kidney Cancer | |||
Official Title ICMJE | A Trial of ZD1839 (Iressa) in Patients With Advanced Renal Cell Carcinoma | |||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Kidney Cancer | |||
Intervention ICMJE | Drug: gefitinib | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | March 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | 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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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00012337 | |||
Other Study ID Numbers ICMJE | CDR0000068507 MSKCC-00125 NCI-1373 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | March 2002 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |