Brief Title
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Official Title
A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid
Brief Summary
This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer
patients with fluid around their lungs or abdomen.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overview of Adverse Events
Secondary Outcome
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Condition
Non-small Cell Lung Cancer
Intervention
pemetrexed
Study Arms / Comparison Groups
Pemetrexed
Description: Pemetrexed 500 mg/m^2 intravenous (IV) every 21 days for 6 cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
31
Start Date
December 2006
Completion Date
March 2009
Primary Completion Date
March 2009
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell
lung cancer (NSCLC) or mesothelioma
- Presence of third-space fluid (fluid around the lungs or abdomen).
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior
to study enrollment, and the patient must have recovered from the sharp toxic effects
the anticancer treatment.
- Estimated life expectancy of at least 8 weeks.
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that was not a marketed
product.
- Active infection that, in the opinion of the investigator, would not allow the patient
to tolerate therapy.
- Pregnancy.
- Breast-feeding.
- Significant weight loss (that is, greater than or equal to 10% of body weight) over
the 6 weeks before study entry.
- Brain metastases.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT00316225
Organization ID
10426
Secondary IDs
H3E-MC-JMHX
Study Sponsor
Eli Lilly and Company
Study Sponsor
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company
Verification Date
June 2010