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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303797 |
RATIONALE: Sorafenib and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of cancer cells by blocking blood flow to the cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and bortezomib in treating patients with advanced cancer.
Condition | Intervention | Phase |
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Leukemia Multiple Myeloma and Plasma Cell Neoplasm Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bortezomib Drug: sorafenib tosylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of the Raf Kinase/VEGFR Inhibitor BAY 43-9006 in Combination With the Proteasome Inhibitor PS-341 in Patients With Advanced Malignancies |
Estimated Enrollment: | 50 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups according to disease type.
Cohorts of 3-6 patients receive escalating doses of sorafenib and bortezomib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients in group II also undergo blood collection periodically during study for mandatory pharmacologic and biomarker correlative studies.
After completion of study treatment, patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 50 patients 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:
Diagnosis of 1 of the following:
Multiple myeloma or chronic lymphocytic leukemia requiring treatment (group II - maximum tolerated dose phase)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since major surgery (e.g., laparotomy) (2 weeks for minor surgery)
No concurrent therapeutic anticoagulation
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Shaji K. Kumar, MD | Mayo Clinic |
Investigator: | Neil E. Kay, MD | Mayo Clinic |
Study ID Numbers: | CDR0000458075, MAYO-MC0511, NCI-7082 |
Study First Received: | March 15, 2006 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00303797 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific stage IV chronic lymphocytic leukemia stage III multiple myeloma refractory multiple myeloma refractory chronic lymphocytic leukemia |
Leukemia, Lymphoid Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders Protein Kinase Inhibitors |
Protease Inhibitors Multiple Myeloma Leukemia Chronic Lymphocytic Leukemia Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Lymphoproliferative Disorders Sorafenib Neoplasms, Plasma Cell |
Immunoproliferative Disorders Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Bortezomib Vascular Diseases Enzyme Inhibitors Paraproteinemias Hemostatic Disorders |
Protein Kinase Inhibitors Pharmacologic Actions Protease Inhibitors Multiple Myeloma Leukemia Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Sorafenib Neoplasms, Plasma Cell |