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Sponsors and Collaborators: |
University of Toronto Eli Lilly and Company |
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Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00470730 |
The purpose of this study is to determine the safety and efficacy of the combination of pemetrexed and cisplatin given concurrently with high dose radiation treatment in patients with unresectable but potentially curable stage IIIA/B non-small cell lung cancer.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Procedure: Radiotherapy Drug: Pemetrexed Drug: Cisplatinum |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Concurrent Pemetrexed/Cisplatin/Radiation in Stage IIIA/B Non-Small Cell Lung Cancer |
Estimated Enrollment: | 49 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | September 2009 |
Concurrent chemoradiation is the accepted standard of care for most patients with unresectable stage III A/B non-small cell lung cancer (NSCLC) but no standard chemotherapy regimen or schedule has yet been established. Cisplatin, combined with a third generation agent, provides the greatest activity in advanced NSCLC but, to date, no third generation agent has been shown to be tolerable at full dose in combination with radiotherapy (RT) and cisplatin.
Pemetrexed/cisplatin (PemC) has shown promising activity in the advanced disease setting and full dose pemetrexed combined with RT or RT/carboplatin appears tolerable. This study was therefore designed to find the maximum tolerable dose of concurrent pemetrexed and cisplatin delivered concurrently with radiation, determine the recommended phase II dose of this regimen and then assess its efficacy in a phase II trial.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have blood tests done within 14 days of the first cycle of chemotherapy indicating normal organ and marrow function as defined below (ULN = upper limit of normal based on institutional policy):
Women must be surgically sterile or postmenopausal, or use a medically approved contraceptive regimen during and for 3 months after treatment.
Women of childbearing potential must have a negative serum pregnancy test within 14 days of initial chemotherapy and must not be lactating.
Exclusion Criteria:
Contact: Shannon Pearson, MRT | 4169464501 ext 3980 | shannon.pearson@rmp.uhn.on.ca |
Contact: Bernadette Southwood, RN | 4169464501 ext 3422 | bernadette.southwood@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G2M9 | |
Principal Investigator: Anthony M Brade, MD CM PhD | |
Sub-Investigator: Frances Shepherd, MD | |
Sub-Investigator: Andrea Bezjak, MD CM MSc | |
Ottawa Regional Cancer Centre | Recruiting |
Ottawa, Ontario, Canada | |
Contact: Kendra Christink, RN 519 737-7700 ext 70308 kchristink@ottawahospital.on.ca | |
Principal Investigator: Robert MacRae, MD | |
Principal Investigator: Scott Laurie, MD |
Principal Investigator: | Anthony M Brade, MD CM PhD | Dept. of Radiation Oncology, Princess Margaret Hospital |
Study ID Numbers: | H3C-CA-JMHU(b) |
Study First Received: | May 7, 2007 |
Last Updated: | May 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00470730 History of Changes |
Health Authority: | Canada: Health Canada |
Radiation Radiotherapy Cisplatinum Pemetrexed |
Lung Cancer Non-small cell lung cancer Phase I Trial Phase II trial |
Antimetabolites Thoracic Neoplasms Folic Acid Antagonists Carcinoma Pemetrexed Folic Acid Respiratory Tract Diseases |
Cisplatin Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Carcinoma |
Pemetrexed Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |