- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190762
A Study Comparing Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Alone in the Treatment of Mesothelioma
January 24, 2007 updated by: Eli Lilly and Company
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
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 Overview
Study Type
Interventional
Enrollment
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H8L6
- 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
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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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
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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
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to compare changes in the average symptom burden index between the Pemetrexed/best supportive care and best supportive care arms
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
January 26, 2007
Last Update Submitted That Met QC Criteria
January 24, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Adenoma
- Neoplasms, Mesothelial
- Pleural Neoplasms
- Mesothelioma
- Mesothelioma, Malignant
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- 5362
- H3E-MC-JMEW
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mesothelioma
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University of ChicagoNational Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Peritoneal Malignant Mesothelioma | Pleural Biphasic Mesothelioma | Pleural Epithelioid Mesothelioma | Pleural Malignant Mesothelioma | Pleural Sarcomatoid Mesothelioma | Recurrent Peritoneal Malignant Mesothelioma | Recurrent Pleural Malignant Mesothelioma and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
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National Cancer Institute (NCI)TerminatedEpithelioid Mesothelioma | Sarcomatoid Mesothelioma | Stage IV Pleural Mesothelioma | Recurrent Malignant Mesothelioma | Stage II Pleural Mesothelioma | Stage III Pleural MesotheliomaUnited States
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National Cancer Institute (NCI)CompletedCediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By SurgeryRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous Mesothelioma | Localized Malignant MesotheliomaUnited States
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National Cancer Institute (NCI)Active, not recruitingBiphasic Mesothelioma | Epithelioid Mesothelioma | Stage III Pleural Malignant Mesothelioma AJCC v7 | Stage I Pleural Malignant Mesothelioma AJCC v7 | Stage IA Pleural Malignant Mesothelioma AJCC v7 | Stage IB Pleural Malignant Mesothelioma AJCC v7 | Stage II Pleural Malignant Mesothelioma AJCC...United States
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Mayo ClinicNational Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Stage IA Malignant Mesothelioma | Stage IB Malignant Mesothelioma | Stage II Malignant Mesothelioma | Stage III Malignant Mesothelioma | Stage IV Malignant MesotheliomaUnited States
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ProgenaBiomeRecruitingMesothelioma | Mesotheliomas Pleural | Mesothelioma Peritoneum | Mesothelioma Malignant | Mesothelioma; Lung | Mesothelioma; Liver | Mesothelioma; OmentumUnited States
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National Cancer Institute (NCI)Active, not recruitingEpithelioid Mesothelioma | Pleural Malignant Mesothelioma | Sarcomatoid Mesothelioma | Recurrent Malignant MesotheliomaUnited States
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National Cancer Institute (NCI)CompletedRecurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma | Epithelial Mesothelioma | Sarcomatous MesotheliomaUnited States
Clinical Trials on Pemetrexed
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Boehringer IngelheimTerminatedCarcinoma, Non-Small-Cell LungJapan
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Shanghai Shengdi Pharmaceutical Co., LtdNot yet recruitingNon-squamous Non-small Cell Lung CancerChina
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Rongjie TaoNational Natural Science Foundation of ChinaUnknown
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Northwestern UniversityNational Cancer Institute (NCI)UnknownLymphoma | Brain and Central Nervous System Tumors | Metastatic CancerUnited States
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PfizerTerminatedCarcinoma, Non-Small Cell LungUnited States, Germany, Italy
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Ain Shams UniversityUnknown
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GlaxoSmithKlineCompletedLung Cancer, Non-Small CellDenmark, United Kingdom
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Eli Lilly and CompanyCompletedNon-Small Cell Lung Cancer Metastatic | Nonsquamous Non-Small Cell Neoplasm of Lung | Non-Small Cell Lung Cancer Stage IIIBUnited Kingdom, Sweden
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Norwegian University of Science and TechnologySt. Olavs HospitalTerminatedCarcinoma, Non-small-cell LungNorway
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University Hospital, AntwerpEli Lilly and Company; Universiteit AntwerpenCompleted