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 on April 18, 2006. Last Updated on June 10, 2010 History of Changes

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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Reporting Groups

	Description
Pemetrexed	Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles

Baseline Measures

	Pemetrexed
Number of Participants [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
Disease Stage ^[2] [units: participants]
Stage III (locally advanced disease)	12
Stage IV (metastatic disease)	18
Unknown	1
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[3] [units: participants]
0 - Fully Active	14
1 - Ambulatory, Restricted Strenuous Activity	17
Fluid Severity ^[4] [units: participants]
Mild	15
Moderate	14
Severe	2
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 )

[1]	Diagnosis of Non-Small Cell Lung Cancer (NSCLC) and mesothelioma were determined by each individual investigator.
[2]	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).
[3]	Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
[4]	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.

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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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.

Limitations and Caveats

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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Results Point of Contact:

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

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00316225 History of Changes
Other Study ID Numbers:	10426, H3E-MC-JMHX
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