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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.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00316225
First received: April 18, 2006
Last updated: June 10, 2010
Last verified: June 2010
Results First Received: March 10, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-small Cell Lung Cancer
Mesothelioma
Lung Neoplasms
Intervention: Drug: pemetrexed

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pemetrexed Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles

Participant Flow:   Overall Study
    Pemetrexed
STARTED   31 
COMPLETED   6 
NOT COMPLETED   25 
Adverse Event                2 
Physician Decision                3 
Progressive Disease                15 
Withdrawal by Subject                3 
Death                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Pemetrexed Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles

Baseline Measures
   Pemetrexed 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Median (Full Range)
 62.7 
 (35.7 to 77.5) 
Gender 
[Units: Participants]
 
Female   4 
Male   27 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   30 
Hispanic   1 
Region of Enrollment 
[Units: Participants]
 
Spain   12 
Denmark   6 
Germany   13 
Diagnosis [1] 
[Units: Participants]
 
Non-Small Cell Lung Cancer (NSCLC)   23 
Mesothelioma   8 
[1] Diagnosis of Non-Small Cell Lung Cancer (NSCLC) and mesothelioma were determined by each individual investigator.
Disease Stage [1] 
[Units: Participants]
 
Stage III (locally advanced disease)   12 
Stage IV (metastatic disease)   18 
Unknown   1 
[1] Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body).
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
 
0 - Fully Active   14 
1 - Ambulatory, Restricted Strenuous Activity   17 
[1] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
Fluid Severity [1] 
[Units: Participants]
 
Mild   15 
Moderate   14 
Severe   2 
[1]

Mild = (1) pleural effusion detectable on radiological imaging, but less than moderate; (2) ascites detectable only by radiological imaging. Moderate = (1) pleural effusion less than 1/3 of the way up the thorax on 1 side on imaging and obscuring the entire hemidiaphragm on that side; (2) ascites detectable on physical exam (that is, fluid wave is palpable). Severe = (1) pleural effusion more than 1/3 of the way up the thorax on imaging; (2) ascites visibly detectable.

For Moderate Fluid Severity, there were 13 patients with pleural effusion and 1 patient with ascites.

Primary Basis for Diagnosis 
[Units: Participants]
 
Cytological   6 
Histopathological   25 
Type of Third-Space Fluid 
[Units: Participants]
 
Pleural Effusion   30 
Ascites   1 
Body Surface Area 
[Units: Meters squared (m^2)]
Median (Full Range)
 1.8 
 (1.4 to 2.3) 
Height 
[Units: Centimeters (cm)]
Median (Full Range)
 171.0 
 (147.0 to 189.0) 
Weight 
[Units: Kilograms (kg)]
Median (Full Range)
 68.0 
 (47.9 to 100.0) 


  Outcome Measures
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1.  Primary:   Overview of Adverse Events   [ Time Frame: baseline, up to 18 weeks ]

2.  Secondary:   Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities   [ Time Frame: baseline, up to 18 weeks ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   Discontinuations Due to Adverse Events   [ Time Frame: baseline, up to 18 weeks ]

6.  Other Pre-specified:   Overall Tumor Response   [ Time Frame: baseline, up to 18 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00316225     History of Changes
Other Study ID Numbers: 10426
H3E-MC-JMHX ( Other Identifier: Eli Lilly and Company )
Study First Received: April 18, 2006
Results First Received: March 10, 2010
Last Updated: June 10, 2010
Health Authority: United States: Food and Drug Administration