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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: | NCT00407550 |
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed disodium together with gemcitabine may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying two different schedules of pemetrexed disodium and gemcitabine to compare how well they work in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | November 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, randomized study. Patients are stratified according to disease stage (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 80 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 non-small cell lung cancer (NSCLC)
No documented brain metastases unless all of the following criteria are met:
PATIENT CHARACTERISTICS:
No severe and/or uncontrolled medical conditions, including any of the following:
No employees of Eli Lilly (i.e., employees, temporary contract workers, or designees responsible for conducting the study)
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000516012, MCCRC-RC0524 |
Study First Received: | December 4, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00407550 |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Folic Acid Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |