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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00316225 |
Purpose
This study will test the effects of pemetrexed on mesothelioma and lung cancer patients with fluid around their lungs or abdomen.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer Mesothelioma Lung Neoplasms |
Drug: pemetrexed |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid |
| Enrollment: | 31 |
| Study Start Date: | December 2006 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| 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. | |
| Kobenhavn, Denmark, 2100 | |
| Germany | |
| 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. | |
| Hannover, Germany, 30625 | |
| 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. | |
| Madrid, Spain, 28041 | |
| 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 |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 10426, H3E-MC-JMHX |
| Study First Received: | April 18, 2006 |
| Last Updated: | March 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00316225 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Thoracic Neoplasms Folate Folinic Acid Folic Acid Antagonists Vitamin B9 Carcinoma Pemetrexed Folic Acid |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Mesothelioma Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Adenoma Neoplasms, Glandular and Epithelial |
|
Antimetabolites Thoracic Neoplasms Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Mesothelial Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Carcinoma |
Pemetrexed Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Mesothelioma Carcinoma, Non-Small-Cell Lung Adenoma Neoplasms, Glandular and Epithelial |