This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.
|First Received Date||April 18, 2006|
|Last Changed Date||June 10, 2010|
|Start Date||December 2006|
|Actual Primary Completion Date||March 2009|
|Primary Outcome Measures||
Overview of Adverse Events [Time Frame: baseline, up to 18 weeks]
|Secondary Outcome Measures||
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities [Time Frame: baseline, up to 18 weeks]
Pemetrexed Population Pharmacokinetics (PK): Clearance [Time Frame: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion]
Pemetrexed Population Pharmacokinetics: Volume of Distribution [Time Frame: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusion]
Discontinuations Due to Adverse Events [Time Frame: baseline, up to 18 weeks]
|Study Arms / Comparison Groups||1 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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.
- 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.
- Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
- Brain metastases.
|Responsible Party||Chief Medical Officer, Eli Lilly|
|Sponsor||Eli Lilly and Company|
|Verification Date||June 2010|