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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00060307 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (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 Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed papillary renal cell cancer, meeting 1 of the following stage criteria:
Prior resection of primary tumor allowed
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
No known history of any of the following corneal diseases:
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Investigator: | Michael S. Gordon, MD | Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea |
Investigator: | Primo N. Lara, MD | University of California, Davis |
Investigator: | Janice P. Dutcher, MD | Our Lady of Mercy Medical Center Comprehensive Cancer Center |
Study ID Numbers: | CDR0000301594, SWOG-S0317, ECOG-S0317 |
Study First Received: | May 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00060307 History of Changes |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer |
Erlotinib Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Recurrence Carcinoma |
Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Erlotinib Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |