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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) Cancer and Leukemia Group B Eastern Cooperative Oncology Group Southwest Oncology Group National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00738881 |
RATIONALE: Pemetrexed and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed is more effective than erlotinib in treating advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying pemetrexed to see how well it works compared with erlotinib when given as second-line therapy in treating patients with advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: erlotinib hydrochloride Drug: pemetrexed disodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non- Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib |
Estimated Enrollment: | 1196 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: erlotinib hydrochloride
Given orally
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Arm II: Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: pemetrexed disodium
Given IV
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC), either on initial diagnosis or at the time of disease recurrence/progression
Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or as ≥ 1.0 cm by spiral CT scan
No nonmeasurable disease only, defined as any of the following:
Previously treated with only one cytotoxic chemotherapy regimen for advanced disease
No brain metastasis, unless the the following criteria are met:
PATIENT CHARACTERISTICS:
No other invasive malignant solid tumor or hematologic malignancy, except for any of the following:
Other prior malignancy diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
Prior low-grade (Gleason score ≤ 6) localized prostate cancer that was diagnosed < 3 years ago allowed
No concurrent severe and/or uncontrolled medical condition, including any of the following:
PRIOR CONCURRENT THERAPY:
No other concurrent chemotherapy, immunotherapy, hormonal therapy, or radiotherapy
Study Chair: | Alex A. Adjei, MD, PhD | Roswell Park Cancer Institute |
Study Chair: | Martin J. Edelman, MD | University of Maryland Greenebaum Cancer Center |
Study Chair: | David P. Carbone, MD, PhD | Vanderbilt-Ingram Cancer Center |
Study Chair: | Fred R. Hirsch, MD, PhD | University of Colorado at Denver and Health Sciences Center |
Study Chair: | Geoffrey Liu, MD | Princess Margaret Hospital, Canada |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000612010, NCCTG-N0723, CALGB-30802, CAN-NCIC-BRC4 |
Study First Received: | August 20, 2008 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00738881 History of Changes |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Antimetabolites Thoracic Neoplasms Erlotinib Folic Acid Antagonists Protein Kinase Inhibitors Recurrence Carcinoma Pemetrexed |
Folic Acid Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Protein Kinase Inhibitors |
Pharmacologic Actions Carcinoma Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |