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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00126594 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: recombinant interferon alfa Drug: sorafenib tosylate Procedure: gene expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase II Clinical Trial to Evaluate the Efficacy of BAY 43-9006 With or Without Low Dose Interferon in Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 80 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance status (0 vs 1), presence of anemia (no vs hemoglobin < 14 g/dL for males OR hemoglobin < 12 g/dL for females), prior nephrectomy (no vs yes), and lactic dehydrogenase (LDH) level (LDH ≤ 1.5 times upper limit of normal (ULN) vs LDH > 1.5 times ULN). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of progressive disease or unacceptable toxicity.
Tissue samples are analyzed for single nucleotide polymorphisms (SNP) patterns via genotyping.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically and cytologically confirmed renal cell carcinoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Must not have any of the following cardiovascular conditions:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation therapy
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Eric Jonasch, MD | M.D. Anderson Cancer Center |
Investigator: | Christopher Logothetis, MD | M.D. Anderson Cancer Center |
Investigator: | Qi Liu, MD, PhD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000437796, MDA-2004-0526, NCI-6629 |
Study First Received: | August 2, 2005 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00126594 |
Health Authority: | United States: Food and Drug Administration |
clear cell renal cell carcinoma stage IV renal cell cancer |
Interferon-alpha Interferon Type I, Recombinant Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases Kidney Neoplasms |
Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Clear cell renal cell carcinoma Sorafenib Interferon Alfa-2b 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 |