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Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
This study has been completed.
Study NCT00316225   Information provided by Eli Lilly and Company
First Received: April 18, 2006   Last Updated: March 26, 2009   History of Changes

April 18, 2006
March 26, 2009
December 2006
March 2009   (final data collection date for primary outcome measure)
Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • This study will evaluate the safety and pharmacokinetics of pemetrexed in patients with third-space fluid. This outcome will be fully evaluated once the last patient receiving study treatment has discontinued from study treatment.
  • Secondary: This study will identify increases in the toxicity of pemetrexed, assess the clinical relevance of any alterations in pemetrexed pharmacokinetics and provide pemetrexed dosing recommendations, in patients with third-space fluid.
Complete list of historical versions of study NCT00316225 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: Yes ]
  • Pemetrexed dosing recommendations [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
This study will identify increases in the toxicity of pemetrexed, assess the clinical relevance of any alterations in pemetrexed pharmacokinetics and provide pemetrexed dosing recommendations, in patients with third-space fluid.
 
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

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

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
  • Non-Small Cell Lung Cancer
  • Mesothelioma
  • Lung Neoplasms
Drug: pemetrexed
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
31
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Spain
 
NCT00316225
Chief Medical Officer, Eli Lilly
10426, H3E-MC-JMHX
Eli Lilly and Company
 
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP