Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
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ClinicalTrials.gov Identifier: NCT00316225 |
Recruitment Status :
Completed
First Posted : April 20, 2006
Results First Posted : July 9, 2010
Last Update Posted : July 9, 2010
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Non-small Cell Lung Cancer Mesothelioma Lung Neoplasms |
Intervention |
Drug: pemetrexed |
Enrollment | 31 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Pemetrexed |
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Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles |
Period Title: Overall Study | |
Started | 31 |
Completed | 6 |
Not Completed | 25 |
Reason Not Completed | |
Adverse Event | 2 |
Physician Decision | 3 |
Progressive Disease | 15 |
Withdrawal by Subject | 3 |
Death | 2 |
Baseline Characteristics
Arm/Group Title | Pemetrexed | |
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Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles | |
Overall Number of Baseline Participants | 31 | |
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[Not Specified]
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Age Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 31 participants | |
62.7
(35.7 to 77.5)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | |
Female |
4 12.9%
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Male |
27 87.1%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Caucasian | 30 | |
Hispanic | 1 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Spain | 12 | |
Denmark | 6 | |
Germany | 13 | |
Diagnosis
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Non-Small Cell Lung Cancer (NSCLC) | 23 | |
Mesothelioma | 8 | |
[1]
Measure Description: Diagnosis of Non-Small Cell Lung Cancer (NSCLC) and mesothelioma were determined by each individual investigator.
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Disease Stage
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Stage III (locally advanced disease) | 12 | |
Stage IV (metastatic disease) | 18 | |
Unknown | 1 | |
[1]
Measure Description: 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).
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Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
0 - Fully Active | 14 | |
1 - Ambulatory, Restricted Strenuous Activity | 17 | |
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
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Fluid Severity
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Mild | 15 | |
Moderate | 14 | |
Severe | 2 | |
[1]
Measure Description:
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. |
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Primary Basis for Diagnosis
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Cytological | 6 | |
Histopathological | 25 | |
Type of Third-Space Fluid
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants |
Pleural Effusion | 30 | |
Ascites | 1 | |
Body Surface Area
Median (Full Range) Unit of measure: Meters squared (m^2) |
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Number Analyzed | 31 participants | |
1.8
(1.4 to 2.3)
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Height
Median (Full Range) Unit of measure: Centimeters (cm) |
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Number Analyzed | 31 participants | |
171.0
(147.0 to 189.0)
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Weight
Median (Full Range) Unit of measure: Kilograms (kg) |
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Number Analyzed | 31 participants | |
68.0
(47.9 to 100.0)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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 |
Other Study ID Numbers: |
10426 H3E-MC-JMHX ( Other Identifier: Eli Lilly and Company ) |
First Submitted: | April 18, 2006 |
First Posted: | April 20, 2006 |
Results First Submitted: | March 10, 2010 |
Results First Posted: | July 9, 2010 |
Last Update Posted: | July 9, 2010 |