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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00087698 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
A: Experimental
chemotherapy, surgery then chest radiation x 54 gray (Gy)
|
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 4 cycles
Drug: cisplatin
75 mg/m2, intravenous (IV), every 21 days x 4 cycles
|
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 7216, H3E-US-JMGA |
| Study First Received: | July 12, 2004 |
| Results First Received: | February 16, 2009 |
| Last Updated: | May 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00087698 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Thoracic Neoplasms Pleural Diseases Adjuvants, Immunologic Folate Folinic Acid Folic Acid Antagonists Vitamin B9 Folic Acid Pemetrexed |
Oxymetazoline Respiratory Tract Diseases Cisplatin Radiation-Sensitizing Agents Phenylephrine Mesothelioma Adenoma Pleural Neoplasms 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 Pleural Diseases Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Pemetrexed Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Respiratory Tract Diseases Therapeutic Uses Mesothelioma Adenoma Pleural Neoplasms Neoplasms, Glandular and Epithelial |