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Clinical Trials >> A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma
Mesothelioma Related Clinical Trials:
A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma
Status: Completed
Sponsors and Collaborators: Eli Lilly and Company
Information provided by: Eli Lilly and Company
Government Identifier: NCT00190762
Condition: Mesothelioma
Intervention: Drug: Pemetrexed
Purpose:
Based on results from earlier clinical trials, Pemetrexed may have antitumor activity as a first-line agent in the treatment of mesothelioma. Given this, it is hypothesized that Pemetrexed may be active in second-line mesothelioma in which the standard treatment is best supportive care. This study will compare survival of previously treated patients with malignant pleural mesothelioma who receive Pemetrexed plus best supportive care to the survival of similar patients who receive best supportive care alone.
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized Phase 3 Trial Comparing ALIMTA Plus Best Supportive Care Versus Best Supportive Care Alone in Previously Treated Patients With Locally Advanced or Metastatic Malignant Pleural Mesothelioma |
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- The primary objective of this study is to compare the overall survival following treatment with Pemetrexed plus best supportive care versus best supportive care alone
Secondary Outcome Measures:
- To characterize and compare the toxicities of Pemetrexed/best supportive care and best supportive care alone in this patient population;to determine the objective-tumor response rate
- to compare time to event efficacy variables of both arms including:duration of response,time to objective tumor response,time to treatment failure,time to documented disease progression,progression-free survival
- to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2001 |
| Estimated Study Completion Date: | November 2005 |
Eligibility:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically proven diagnosis of mesothelioma of the pleura.
- received only one prior systemic chemotherapy regimen for advanced or metastatic disease
- Performance status of 70 or higher on the Karnofsky Performance Status Scale
- Males or females at least 18 years of age
- Adequate organ function
Exclusion Criteria:
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy
- Pregnancy or breastfeeding
- Brain metastasis
- Prior treatment with Pemetrexed
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190762Locations
| Canada, Ontario | |||||
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9:00 AM - 5:00 PM Eastern Time (UTC/GMT - 5 hrs, EST), or speak with your personal physician | |||||
| Ottawa, Ontario, Canada, K1H8L6 | |||||
Sponsors and Collaborators
| Eli Lilly and Company |
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT-5 hours, EST) | Eli Lilly and Company |
Additional Information:
| Study ID Numbers: | 5362, H3E-MC-JMEW |
| First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00190762 |
| Health Authority: | United States: Food and Drug Administration |
Study placed in the following topic categories:
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Additional relevant MeSH terms:
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