ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.
Primary Purpose
Mesothelioma
Status
Approved for marketing
Phase
Locations
International
Study Type
Expanded Access
Intervention
Pemetrexed
Cisplatin
Sponsored by
About this trial
This is an expanded access trial for Mesothelioma
Eligibility Criteria
Inclusion Criteria: Have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery Prior chemotherapy for your disease is allowed Measurable lesion is not required Have a adequate performance status Sign an informed consent form Exclusion Criteria: You are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study You are excluded from this trial if you have received radiation within the previous 2 weeks You are excluded from this trial if you are a candidates for curative surgery
Sites / Locations
- For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
- For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
- "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
- For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
- For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00040625
Brief Title
ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients who qualify for treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Type
Drug
Intervention Name(s)
Cisplatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery
Prior chemotherapy for your disease is allowed
Measurable lesion is not required
Have a adequate performance status
Sign an informed consent form
Exclusion Criteria:
You are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study
You are excluded from this trial if you have received radiation within the previous 2 weeks
You are excluded from this trial if you are a candidates for curative surgery
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
City
Sao Paulo
Country
Brazil
Facility Name
"For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician."
City
Cairo
Country
Egypt
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
City
Cairo
Country
Egypt
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician
City
Jeddah
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.
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