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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00660816 |
RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving pemetrexed disodium together with erlotinib is more effective than giving pemetrexed disodium alone in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is studying pemetrexed disodium and erlotinib to see how well they work compared with pemetrexed disodium alone in treating patients with stage IIIB or stage IV non-small cell lung cancer that responded to previous erlotinib.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: erlotinib hydrochloride Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Randomized Phase II Trial, Comparing Pemetrexed Disodium Plus Erlotinib to Pemetrexed Disodium Alone in EGFR TKI-Responsive Non-Small Cell Lung Cancer |
Estimated Enrollment: | 78 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
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Drug: pemetrexed disodium
Given IV
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Arm II: Experimental
Patients receive pemetrexed disodium IV over 10 minutes on day 1 and oral erlotinib hydrochloride once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease after 8 courses may continue to receive oral erlotinib hydrochloride alone once daily in the absence of disease progression or unacceptable toxicity.
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Drug: erlotinib hydrochloride
Given orally
Drug: pemetrexed disodium
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to lifetime smoking status (never vs ever) and ECOG performance status (0-1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.
Patients complete a smoking status survey at baseline and then every 3 months thereafter.
After completion of study treatment, patients are followed at approximately 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed non-small cell lung cancer
Baseline diagnostic tumor specimen available for correlative studies
No active CNS metastases as indicated by clinical symptoms, cerebral edema, or progressive growth
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No more than 1 prior cytotoxic chemotherapy regimen for relapsed or metastatic disease
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Cleveland Clinic Taussig Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
Geauga Regional Hospital | Recruiting |
Cleveland, Ohio, United States, 44024 | |
Contact: Balazs Halmos 216-368-3362 | |
Lake/University Ireland Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44060 | |
Contact: Balazs Halmos 216-368-3362 | |
University Suburban Health Center | Recruiting |
Cleveland, Ohio, United States, 44121 | |
Contact: Balazs Halmos 216-368-3362 | |
Southwest General Health Center | Recruiting |
Cleveland, Ohio, United States, 44130 | |
Contact: Balazs Halmos 216-368-3362 | |
UHHS Chagrin Highlands Medical Center | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Balazs Halmos 216-368-3362 | |
UHHS Westlake Medical Center | Recruiting |
Cleveland, Ohio, United States, 44145 | |
Contact: Balazs Halmos 216-368-3362 | |
Mercy Cancer Center at Mercy Medical Center | Recruiting |
Cleveland, Ohio, United States, 44708 | |
Contact: Balazs Halmos 216-368-3362 |
Study Chair: | Balazs Halmos, MD | Ireland Cancer Center |
Responsible Party: | Ireland Cancer Center at University Hospitals/Case Medical Center ( Balazs Halmos ) |
Study ID Numbers: | CDR0000593995, CASE-2507 |
Study First Received: | April 16, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00660816 |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Folic Acid Erlotinib Pemetrexed Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |