Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118170 |
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Sorafenib may have different effects in patients who have changes in their liver or kidney function.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating patients with metastatic or unresectable solid tumors, multiple myeloma, or non-Hodgkin's lymphoma with or without impaired liver or kidney function.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Unspecified Adult Solid Tumor, Protocol Specific |
Drug: sorafenib tosylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pharmacokinetic and Phase I Study of Sorafenib (BAY 43-9006, NSC 724772, IND 69896) For Solid Tumors and Hematologic Malignancies in Patients With Hepatic or Renal Dysfunction |
Estimated Enrollment: | 120 |
Study Start Date: | October 2004 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study. Patients are assigned to 1 of 9 treatment cohorts according to hepatic or renal function.
Patients receive oral sorafenib once on day 1 and then once daily, twice daily, or every other day beginning on day 8 and continuing for 3 months.
Patients are re-evaluated at 3 months. Patients with responding disease may continue study treatment in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients (per treatment cohort) receive escalating doses of sorafenib until the maximum tolerated dose (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. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 120 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:
Histologically or cytologically confirmed solid tumor, multiple myeloma, or non-Hodgkin's lymphoma
Measurable or non-measurable disease
The following are considered nonmeasurable disease:
Hepatic or renal function meeting 1 of the following criteria*:
Brain metastases allowed provided all of the following criteria are met:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No evidence of biliary obstruction
Renal
No evidence of renal obstruction
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
United States, California | |
Moores UCSD Cancer Center | |
La Jolla, California, United States, 92093-0658 | |
Veterans Affairs Medical Center - San Diego | |
San Diego, California, United States, 92161 | |
United States, Connecticut | |
Norwalk Hospital | |
Norwalk, Connecticut, United States, 06856 | |
United States, District of Columbia | |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
Washington, District of Columbia, United States, 20007 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Study Chair: | Antonius A. Miller, MD | Wake Forest University |
Study ID Numbers: | CDR0000433342, CALGB-60301 |
Study First Received: | July 8, 2005 |
Last Updated: | March 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00118170 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific stage III multiple myeloma recurrent adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma recurrent adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma |
stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma recurrent grade 3 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent mantle cell lymphoma Waldenstrom macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma splenic marginal zone lymphoma |
Blood Protein Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Lymphoma, B-Cell, Marginal Zone Paraproteinemias Hemostatic Disorders Protein Kinase Inhibitors Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Hemorrhagic Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-cell Leukemia, B-cell, Chronic Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Recurrence Multiple Myeloma Burkitt's Lymphoma Lymphatic Diseases Chronic Lymphocytic Leukemia |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Hematologic Diseases Blood Protein Disorders Vascular Diseases Enzyme Inhibitors Paraproteinemias Hemostatic Disorders Protein Kinase Inhibitors |
Pharmacologic Actions Multiple Myeloma Lymphatic Diseases Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Sorafenib Lymphoma Neoplasms, Plasma Cell |