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Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma
This study has been completed.
Study NCT00087698   Information provided by Eli Lilly and Company
First Received: July 12, 2004   Last Updated: May 1, 2009   History of Changes
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Condition: Pleural Neoplasms
Interventions: Drug: pemetrexed
Drug: cisplatin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Participant Flow:   Overall Study
  Pemetrexed
STARTED   77  
COMPLETED   41  
NOT COMPLETED   36  
      Lack of Efficacy, Progressive Disease               14  
      Death from Other Causes               3  
      Adverse Event               4  
      Withdrawal by Subject               4  
      Lack of Efficacy, Physician Perception               3  
      Protocol Entry Criteria Not Met               2  
      Clinical Relapse               1  
      Death from Study Disease               2  
      Death from Study Drug Toxicity               2  
      Protocol Violation               1  



  Baseline Characteristics
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Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Baseline Measures
  Pemetrexed
Number of Participants  
[units: participants]
 		77
Age  
[units: years]
Mean ± Standard Deviation 		61.1 ± 9.38
Gender  
[units: participants]
 		 
Female 21
Male 56
Region of Enrollment  
[units: participants]
 		 
United States 77
Disease Stage at Time of Study Entry  
[units: participants]
 		 
Stage IA 3
Stage IB 3
Stage II 33
Stage III 35
Stage IV 1
Unknown/Not Available 2
Eastern Cooperative Oncology Group Performance Status  
[units: participants]
 		 
0 - Fully active and asymptomatic 28
1 - Ambulatory with symptoms 47
2 - In bed < 50% of time 2
Initial Pathological Diagnosis  
[units: participants]
 		 
Epithelial Mesothelioma 62
Mixed Cell Mesothelioma 2
Sarcomatoid Mesothelioma 1
Other 12
Race/Ethnicity  
[units: participants]
 		 
Caucasian 71
African 1
East/Southeast Asian 1
Western Asian 2
Hispanic 2
Time from Initial Pathological Diagnosis to Enrollment  
[units: months]
Mean ± Standard Deviation 		2.19 ± 2.909



  Outcome Measures
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1.  Primary:   Pathological Complete Response   [ Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ]

Measure Type Primary
Measure Title Pathological Complete Response
Measure Description

Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]).

Resected tissue or pleural fluid should be sent for pathological and histological evaluation.
Time Frame Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)  
Safety Issue No  

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.
All participants who had undergone surgery.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Measured Values
  Pemetrexed
Number of Participants Analyzed
[units: participants] 		57
Pathological Complete Response
[units: participants]
 		3

No statistical analysis provided for Pathological Complete Response



2.  Secondary:   The 1 and 2 Year Disease-Free Survival Rate (Percentage)   [ 1 year and 2 years ]

Measure Type Secondary
Measure Title The 1 and 2 Year Disease-Free Survival Rate (Percentage)
Measure Description Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.
Time Frame 1 year and 2 years  
Safety Issue No  

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.
All participants who had undergone surgery.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Measured Values
  Pemetrexed
Number of Participants Analyzed
[units: participants] 		57
The 1 and 2 Year Disease-Free Survival Rate (Percentage)
[units: percentage of participants]
Mean ( 95% Confidence Interval ) 		 
1-Year Disease-Free Rate 61.40
( 47.53 to 72.63 )
2-Year Disease-Free Rate 33.24
( 21.45 to 45.47 )

No statistical analysis provided for The 1 and 2 Year Disease-Free Survival Rate (Percentage)



3.  Secondary:   Overall Tumor Response   [ baseline to measured progressive disease ]

Measure Type Secondary
Measure Title Overall Tumor Response
Measure Description The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
Time Frame baseline to measured progressive disease  
Safety Issue No  

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.
Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Measured Values
  Pemetrexed
Number of Participants Analyzed
[units: participants] 		77
Overall Tumor Response
[units: participants]
 		 
Complete Response 1
Partial Response 24
Stable Disease 36
Progressive Disease 5
Unknown/Unavailable 11

No statistical analysis provided for Overall Tumor Response



4.  Secondary:   Time to Treatment Failure   [ baseline to stopping treatment ]

Measure Type Secondary
Measure Title Time to Treatment Failure
Measure Description Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.
Time Frame baseline to stopping treatment  
Safety Issue Yes  

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.
All participants who had undergone surgery.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Measured Values
  Pemetrexed
Number of Participants Analyzed
[units: participants] 		57
Time to Treatment Failure
[units: months]
Mean ( Full Range ) 		18.30
( 1.71 to 41.89 )

No statistical analysis provided for Time to Treatment Failure



5.  Secondary:   Time to Progressive Disease   [ baseline to measured progressive disease ]

Measure Type Secondary
Measure Title Time to Progressive Disease
Measure Description Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.
Time Frame baseline to measured progressive disease  
Safety Issue No  

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.
All participants who had undergone surgery.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Measured Values
  Pemetrexed
Number of Participants Analyzed
[units: participants] 		57
Time to Progressive Disease
[units: months]
Mean ( Full Range ) 		14.98
( 2.56 to 46.00 )

No statistical analysis provided for Time to Progressive Disease



6.  Secondary:   Overall Survival Time   [ baseline to date of death from any cause ]

Measure Type Secondary
Measure Title Overall Survival Time
Measure Description Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).
Time Frame baseline to date of death from any cause  
Safety Issue Yes  

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.
All participants who had undergone surgery.

Reporting Groups
  Description
Pemetrexed pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)

Measured Values
  Pemetrexed
Number of Participants Analyzed
[units: participants] 		57
Overall Survival Time
[units: months]
Mean ( Full Range ) 		21.85
( 3.25 to 46.00 )

No statistical analysis provided for Overall Survival Time




  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:
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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided


Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 7216, H3E-US-JMGA
Study First Received: July 12, 2004
Results First Received: February 16, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00087698     History of Changes
Health Authority: United States: Food and Drug Administration





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