Last Updated: January 21, 2008
Clinical Trial Phase: Phase 2 Start Date: December 2006
Overall Status: Recruiting
Estimated Enrollment: 30

Condition Keyword(s):
• Non-Small Cell Lung Cancer
• Mesothelioma
• Lung Neoplasms

Intervention(s):
• Drug: pemetrexed

Rationale

This study will test the effects of pemetrexed on mesothelioma and lung cancer patients with fluid around their lungs or abdomen.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Outcome Measures for this Clinical Trial

Primary: Pharmacology toxicity every cycle

Secondary:
• Adverse events every cycle
• Pharmacokinetics cycle 1, cycle 2
• Pemetrexed dosing recommendations every cycle

Inclusion Criteria

• Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer or mesothelioma

• Presence of third-space fluid (fluid around the lungs or abdomen).

• Measurable lesions are not required for enrollment in this study.

• 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.

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
København 2100 Denmark

Overall Clinical Trial Officials and 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) Study Director Eli Lilly and Company

Overall Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Additional Information

Information obtained from ClinicalTrials.gov on April 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00316225
Study ID Number: 10426
ClinicalTrials.gov Identifier: NCT00316225

Labels: ClinicalTrial