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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:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00040625
First received: July 2, 2002
Last updated: March 14, 2007
Last verified: March 2007
  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 Phase
Mesothelioma
Drug: Pemetrexed
Drug: Cisplatin
Phase 2

Study Type: Expanded Access     What is Expanded Access?

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00040625     History of Changes
Other Study ID Numbers: 6093, H3E-US-JMFE
Study First Received: July 2, 2002
Last Updated: March 14, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cisplatin
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014