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

Sponsor:

Information provided by:

Eli Lilly and Company

Study Type:	Interventional
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

Participant Flow

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Recruitment Details

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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]

Age
[Units: Years]
Median (Full Range)

62.7
(35.7 to 77.5)

Gender
[Units: Participants]

Female

Male

Race/Ethnicity, Customized
[Units: Participants]

Caucasian

Hispanic

Region of Enrollment
[Units: Participants]

Spain

Denmark

Germany

Diagnosis ^[1]
[Units: Participants]

Non-Small Cell Lung Cancer (NSCLC)

Mesothelioma

^[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)

Stage IV (metastatic disease)

Unknown

^[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

1 - Ambulatory, Restricted Strenuous Activity

^[1]	Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Fluid Severity ^[1]
[Units: Participants]

Mild

Moderate

Severe

^[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

Histopathological

Type of Third-Space Fluid
[Units: Participants]

Pleural Effusion

Ascites

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 ]

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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 ]

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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 ]

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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 ]

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5. Secondary:

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

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6. Other Pre-specified:

Overall Tumor Response [ Time Frame: baseline, up to 18 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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 )
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

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