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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00352443 |
RATIONALE: Lapatinib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Everolimus may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving lapatinib together with everolimus may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and everolimus in treating patients with advanced solid tumors or non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: everolimus Drug: lapatinib ditosylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989) and Everolimus (RAD001) in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 48 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study followed by a randomized study. Initial patients enrolled on the study are treated in part I. After the maximum tolerated dose (MTD) is determined in part I, subsequent patients are enrolled and treated in part II.
Cohorts of 3-6 patients receive escalating doses of everolimus and lapatinib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Part II: Patients are randomized to 1 of 2 treatment arms. Everolimus and lapatinib are administered at the MTD determined in part I.
Patients in part II undergo blood collection periodically for correlative biomarker and pharmacokinetic studies.
After finishing treatment, patients are followed periodically for 28 days.
PROJECTED ACCRUAL: A total of 48 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:
Patients with brain metastases who require corticosteroids or anticonvulsants must be on a stable or decreasing dose of corticosteroids and seizure free for 30 days prior to study entry
Patients with known brain metastases must have had brain irradiation (whole brain or gamma knife)
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent chemotherapy, hormone therapy, radiotherapy, immunotherapy, live vaccines or any other anticancer therapy
No concurrent gastric H2 blockers (e.g., cimetidine, ranitidine, nizatidine, famotidine) or proton pump inhibitors (e.g., omeprazole, esomeprazole, rabeprazole, pantoprazole, or lansoprazole)
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
United States, Kentucky | |
Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536-0093 | |
Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109-0942 | |
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
United States, Washington | |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Recruiting |
Seattle, Washington, United States, 98122-4307 | |
Contact: Saul E. Rivkin, MD 206-386-2441 | |
University Cancer Center at University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195-6043 | |
Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 |
Study Chair: | Shirish M. Gadgeel, MD | Barbara Ann Karmanos Cancer Institute |
Investigator: | Patricia M. LoRusso, DO | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000486867, SWOG-S0528 |
Study First Received: | July 13, 2006 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00352443 |
Health Authority: | Unspecified |
adult grade III lymphomatoid granulomatosis recurrent adult grade III lymphomatoid granulomatosis Waldenstrom macroglobulinemia recurrent adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma |
recurrent small lymphocytic lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Lymphoma, large-cell, immunoblastic Lymphoma, large-cell Lymphoma, B-Cell Lymphomatoid granulomatosis Burkitt's lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Waldenstrom macroglobulinemia Lymphoma |
Everolimus Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Leukemia, B-cell, chronic Immunoblastic Lymphadenopathy Lapatinib Lymphoblastic lymphoma Mantle cell lymphoma Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Burkitt Lymphoma B-cell lymphomas |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Immunosuppressive Agents Pharmacologic Actions |