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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00475657 |
The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.
Condition | Intervention | Phase |
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Small Cell Lung Cancer |
Drug: pemetrexed Drug: cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer |
Enrollment: | 5 |
Study Start Date: | October 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: pemetrexed
500 mg/m2, IV, q 21 days x 6 cycles
Drug: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Ferrol, Spain, 15405 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
La Coruña, Spain, 15002 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Lugo, Spain, 27004 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Vigo, Spain, 36211 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Santiago de Compostela, Spain, 15706 | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Ourense, Spain, 15009 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 11473, H3E-XM-S113 |
Study First Received: | May 16, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00475657 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Antimetabolites Thoracic Neoplasms Carcinoma, Neuroendocrine Folic Acid Antagonists Carcinoma Neuroendocrine Tumors Folic Acid Pemetrexed Carcinoma, Small Cell Neuroectodermal Tumors |
Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Carcinoma, Neuroendocrine Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Respiratory Tract Neoplasms |
Neoplasms by Histologic Type Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Pemetrexed Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |