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Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00350792
First received: July 10, 2006
Last updated: October 11, 2010
Last verified: October 2010
History of Changes
Results First Received: November 5, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: pemetrexed
Drug: carboplatin

  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 + Carboplatin

Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.

Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.

Participant Flow:   Overall Study
    Pemetrexed + Carboplatin  
STARTED     62  
COMPLETED     29  
NOT COMPLETED     33  
Adverse Event                 11  
Death from Study Disease                 1  
Death from Study Drug Toxicity                 1  
Death Not Study Drug Related                 2  
Protocol Violation                 1  
Withdrawal by Subject                 4  
Physician Decision                 2  
Lack of Efficacy                 11  



  Baseline Characteristics
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Reporting Groups
  Description
Pemetrexed + Carboplatin

Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.

Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.

Baseline Measures
    Pemetrexed + Carboplatin  
Number of Participants  
[units: participants]
 		  62  
Age  
[units: years]
Mean ± Standard Deviation 		  76.5  ± 3.6  
Gender  
[units: participants]
 		 
Female     11  
Male     51  
Region of Enrollment  
[units: participants]
 		 
France     62  
Disease Stage [1]
[units: participants]
 		 
Stage IIIB     13  
Stage IV     49  
Eastern Cooperative Oncology Group (ECOG) Performance Status [2]
[units: participants]
 		 
0 - Fully Active     10  
1 - Ambulatory, Restricted Strenuous Activity     52  
Pathological Diagnosis  
[units: participants]
 		 
Large Cell Lung Cancer     5  
Adenocarcinoma of Lung     32  
Squamous Cell Carcinoma of Lung     21  
Other: Carcinoma-Infiltrant Indifferencie     1  
Other: Carcinoma     1  
Other: Indifferencied Non-Small Cell Lung Cancer     1  
Other: Undifferentiated     1  
[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).
[2] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)   [ Time Frame: baseline to measured objective tumor response (up to six 21-day cycles) ]
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2.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to stopping treatment (up to six 21-day cycles) ]
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3.  Secondary:   Overall Survival   [ Time Frame: baseline to date of death from any cause (up to 14.5 months) ]
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4.  Secondary:   Estimated Probability of One Year Progression-free Survival   [ Time Frame: baseline to measured progressive disease or death, 1 year ]
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5.  Other Pre-specified:   Time to Treatment Failure   [ Time Frame: baseline to stopping treatment (up to six 21-day cycles) ]
  Show Outcome Measure 5


  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
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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: NCT00350792     History of Changes
Other Study ID Numbers: 9941, H3E-FP-S099
Study First Received: July 10, 2006
Results First Received: November 5, 2009
Last Updated: October 11, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)