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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.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00087698
First received: July 12, 2004
Last updated: May 1, 2009
Last verified: May 2009
Results First Received: February 16, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
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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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.
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)

Baseline Measures
   Pemetrexed 
Overall Participants Analyzed 
[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   [ Time Frame: Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ]

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

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

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

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

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


  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: 1-800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00087698     History of Changes
Obsolete Identifiers: NCT00072397
Other Study ID Numbers: 7216
H3E-US-JMGA
Study First Received: July 12, 2004
Results First Received: February 16, 2009
Last Updated: May 1, 2009
Health Authority: United States: Food and Drug Administration