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

This treatment has been approved for sale to the public.

First Received: July 2, 2002 Last Updated: March 14, 2007 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00040625

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 II

Study Type:

Expanded Access

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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

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
Sao Paulo, Brazil
Brazil, RS
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
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

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

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists

Pharmacologic Actions
Pemetrexed
Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009