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Sponsors and Collaborators: |
Institute for Drug Development National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045487 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: erlotinib hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II, Pharmacokinetic And Biologic Correlative Study Of OSI-774, An EGFR Tyrosine Inhibitor, In Patients With Advanced Renal Cell Carcinoma |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced renal cell carcinoma (RCC)
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Opthalmic
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
San Antonio Cancer Institute | |
San Antonio, Texas, United States, 78229-3264 |
Study Chair: | Anthony W. Tolcher, MD | San Antonio Cancer Institute |
Study ID Numbers: | CDR0000256598, SACI-IDD0127, NCI-5410 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045487 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Erlotinib Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |