ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.
This treatment has been approved for sale to the public.
Sponsor:
Eli Lilly and Company
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
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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
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 Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Pemetrexed Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013