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  • Home > Blog > Clinical Trial > Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Posted on Saturday, Mar 1, 2008

Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

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