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ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00040625
First Posted: July 4, 2002
Last Update Posted: March 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
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.

Condition Intervention
Mesothelioma Drug: Pemetrexed Drug: Cisplatin

Study Type: Expanded Access     What is Expanded Access?

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040625


Locations
United States, New Jersey
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.
Basking Ridge, New Jersey, United States
Brazil
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
Porto Alegre, RS, Brazil
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
Sao Paulo, Brazil
Egypt
"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."
Cairo, Egypt
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
Cairo, Egypt
Saudi Arabia
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
Jeddah, Saudi Arabia
Sponsors and Collaborators
Eli Lilly and Company
  More Information

ClinicalTrials.gov Identifier: NCT00040625     History of Changes
Other Study ID Numbers: 6093
H3E-US-JMFE
First Submitted: July 2, 2002
First Posted: July 4, 2002
Last Update Posted: March 15, 2007
Last Verified: March 2007

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors