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A Study of Thymidylate Synthase Expression in Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00887549
First received: April 23, 2009
Last updated: June 7, 2012
Last verified: June 2012
Results First Received: July 29, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
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
The trial consists of induction therapy (up to 4 cycles of pemetrexed-cisplatin treatment) and maintenance therapy (pemetrexed only). Only participants who do not develop disease progression during induction therapy are eligible to receive maintenance therapy.

Reporting Groups
  Description
Pemetrexed Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs

Participant Flow for 2 periods

Period 1:   Induction Therapy
    Pemetrexed  
STARTED     70  
COMPLETED     43  
NOT COMPLETED     27  
Adverse Event                 8  
Physician Decision                 1  
Progressive Disease                 13  
Death due to Study Disease                 4  
Death due to Study Drug Toxicity                 1  

Period 2:   Maintenance Therapy
    Pemetrexed  
STARTED     43  
COMPLETED     0  
NOT COMPLETED     43  
Adverse Event                 16  
Physician Decision                 1  
Progressive Disease                 25  
Death due to adverse event                 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 Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs

Baseline Measures
    Pemetrexed  
Number of Participants  
[units: participants]
  70  
Age  
[units: years]
Mean ± Standard Deviation
  63.0  ± 9.42  
Gender  
[units: participants]
 
Female     32  
Male     38  
Race/Ethnicity, Customized  
[units: participants]
 
Caucasian     69  
Asian     1  
Region of Enrollment  
[units: participants]
 
Ireland     4  
United Kingdom     66  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 
0- Fully active     24  
1- Ambulatory, Restricted Strenuous Activity     46  
Pathological Diagnosis  
[units: participants]
 
Adenocarcinoma, not otherwise specified (NOS)     34  
Adenocarcinoma, acinar     1  
Adenocarcinoma, poorly differentiated     20  
Bronchioalveolar Carcinoma     6  
Carcinoma, Non-Small Cell, Lung (NSCL), (NOS)     3  
Carcinoma, NSC, Poorly Differentiated, Lung     5  
Carcinoma, undifferentiated     1  
Past and Current Tobacco Usage  
[units: participants]
 
Never used tobacco products     6  
Ever used tobacco products     64  
[1] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Baseline to measured progressive disease with follow-up every 6 weeks until progression of disease (up to 18 months after the last participant commenced induction therapy) ]

2.  Secondary:   Percentage of Participants With Tumor Response (Tumor Response Rate)   [ Time Frame: Baseline to disease progression (up to 20 months) ]

3.  Secondary:   Percentage of Participants With Concordance Between Local and Central Histological Diagnosis   [ Time Frame: Baseline ]

4.  Secondary:   Percentage of Participants Surviving at 18 Months (Overall Survival Rate)   [ Time Frame: Baseline to date of death (up to 24.5 months) ]


  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
No text entered.


  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: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00887549     History of Changes
Other Study ID Numbers: 13069, H3E-BP-JMIK
Study First Received: April 23, 2009
Results First Received: July 29, 2011
Last Updated: June 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Ireland: Irish Medicines Board
Ireland: Medical Ethics Research Committee