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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470405 |
RATIONALE: Pemetrexed may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed given together with oxaliplatin in treating patients with metastatic solid tumors or lymphoma.
Condition | Intervention | Phase |
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Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: oxaliplatin Drug: pemetrexed disodium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of ALIMTA Plus Oxaliplatin Administered Every Other Week in the Treatment of Patients With Metastatic Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | May 2004 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive pemetrexed disodium IV over 10 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pemetrexed disodium and oxaliplatin 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. Once the MTD is determined, the recommended phase II dose will be identified.
After completion of study treatment, patients are followed at 30 days and then periodically thereafter.
PROJECTED ACCRUAL: A total of 36 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:
Metastatic disease
No clinically relevant third-space fluid collections
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 |
Principal Investigator: | Mace L. Rothenberg, MD, FACP | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000543763, VU-VICC-PHI-0367, LILLY-H3E-US-S053A, VU-IRB-031027 |
Study First Received: | May 3, 2007 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00470405 |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific stage IV adult Hodgkin lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma cutaneous B-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma adult nasal type extranodal NK/T-cell lymphoma adult grade III lymphomatoid granulomatosis Waldenstrom macroglobulinemia stage IV adult Burkitt 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 |
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma nodal marginal zone B-cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma |
Sezary syndrome Hodgkin's disease Hodgkin lymphoma, adult Cutaneous T-cell lymphoma Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Lymphoma, large-cell, immunoblastic Lymphoma, large-cell Lymphoma, B-Cell Lymphomatoid granulomatosis Burkitt's lymphoma |
Mycoses Oxaliplatin Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Waldenstrom macroglobulinemia Hodgkin Disease Lymphoma Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Leukemia, B-cell, chronic |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |