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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00101114 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with metastatic or unresectable kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: recombinant interferon alfa Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of the RAF-Kinase Inhibitor BAY 43-9006 (NSC0724772, IND 69,896) in Combination With Interferon-α2B in Patients With Advanced Renal Cancer |
Study Start Date: | September 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28 and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. 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 55 patients will be accrued for this study within 8-9 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell cancer (RCC)
Must have a component of clear cell RCC
Patients with any of the following are not eligible:
Measurable disease
No prior or current brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent systemic corticosteroid therapy
Radiotherapy
Surgery
Other
No concurrent inhibitors of CYP3A4 enzyme, including any of the following:
Investigator: | Christopher W. Ryan, MD | Oregon Health and Science University Cancer Institute |
Investigator: | Tomasz M. Beer, MD | Oregon Health and Science University Cancer Institute |
Study ID Numbers: | CDR0000405893, SWOG-S0412 |
Study First Received: | January 7, 2005 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00101114 |
Health Authority: | United States: Federal Government |
stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer |
Interferon-alpha Interferon Type I, Recombinant Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Clear cell renal cell carcinoma Sorafenib Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |