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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00087698 |
This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.
Condition | Intervention | Phase |
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Pleural Neoplasms |
Drug: pemetrexed Drug: cisplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma |
Enrollment: | 77 |
Study Start Date: | September 2003 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
chemotherapy, surgery then chest radiation x 54 Gy
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Drug: pemetrexed
500 mg/m2, IV, q 21 days x 4 cycles
Drug: cisplatin
75 mg/m2, IV, q 21 days x 4 cycles
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:
Exclusion Criteria:
Patients will be excluded if they meet ANY of the following criteria:
United States, California | |
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. | |
San Francisco, California, United States | |
United States, Illinois | |
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. | |
Chicago, Illinois, United States | |
United States, Maryland | |
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. | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
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. | |
Boston, Massachusetts, United States | |
United States, Michigan | |
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. | |
Detroit, Michigan, United States | |
United States, New York | |
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. | |
New York, New York, United States | |
United States, Texas | |
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. | |
Houston, Texas, United States |
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: | 7216, H3E-US-JMGA |
Study First Received: | July 12, 2004 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00087698 |
Health Authority: | United States: Food and Drug Administration |
Thoracic Neoplasms Pleural Diseases Folic Acid Pemetrexed Naphazoline Oxymetazoline Cisplatin Respiratory Tract Diseases |
Phenylephrine Guaifenesin Mesothelioma Phenylpropanolamine Adenoma Pleural Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |