Chemotherapy for Patients With Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00380718
First received: September 22, 2006
Last updated: November 1, 2010
Last verified: November 2010
Results First Received: September 2, 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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty-seven participants were screened; 3 did not meet inclusion/exclusion criteria and one withdrew.

Reporting Groups
  Description
Pemetrexed 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).

Participant Flow:   Overall Study
    Pemetrexed  
STARTED     33  
Received at Least One Dose of Study Drug     33  
Received Escalated Dose in Cycle 2     25  
COMPLETED     15  
NOT COMPLETED     18  
Adverse Event                 1  
Death after 30-day post-therapy followup                 17  



  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 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).

Baseline Measures
    Pemetrexed  
Number of Participants  
[units: participants]
  33  
Age  
[units: years]
Mean ± Standard Deviation
  58.0  ± 11.27  
Gender  
[units: participants]
 
Female     13  
Male     20  
Region of Enrollment  
[units: participants]
 
Taiwan     33  
Disease Characteristic: Basis for Diagnosis  
[units: participants]
 
Histopathological     17  
Cytological     16  
Disease Characteristic: Disease Stage at Study Entry [1]
[units: participants]
 
Stage IIIB     3  
Stage IV     30  
Disease Characteristic: Eastern Cooperative Oncology Group Performance Status [2]
[units: participants]
 
0 - Fully Active     9  
1 - Ambulatory, Restricted Strenuous Activity     24  
Disease Characterstic: Pathological Diagnosis Code  
[units: participants]
 
Adenocarcinoma of Lung     23  
Large Cell Carcinoma of Lung     1  
Mixed Cell     0  
Squamous Cell Carcinoma of Lung     8  
Non-Small Cell Lung Carcinoma     1  
Race/Ethnicity  
[units: participants]
 
East/Southeast Asian     33  
Smoking Status  
[units: participants]
 
Ever Smoking     20  
Never Smoking     13  
24 Hour Creatinine Clearance [3]
[units: milliliters per minute (ml/min)]
Mean ± Standard Deviation
  81.142  ± 24.9265  
Body Temperature  
[units: degrees Celcius (°C)]
Mean ± Standard Deviation
  36.25  ± 0.336  
Disease Characteristic: Time from Initial Diagnosis to Prior Chemotherapy Failure [4]
[units: months]
Mean ± Standard Deviation
  12.04  ± 23.764  
Disease Characteristic: Time from Initial Diagnosis to Study Entry  
[units: months]
Mean ± Standard Deviation
  11.54  ± 20.829  
Disease Characteristic: Time from Prior Chemotherapy Failure to Study Entry [4]
[units: months]
Mean ± Standard Deviation
  1.00  ± 0.486  
Heart Rate  
[units: beats per minute (bpm)]
Mean ± Standard Deviation
  87.5  ± 15.00  
Height  
[units: centimeters]
Mean ± Standard Deviation
  162.0  ± 8.59  
Homocysteine  
[units: micromoles per Liter (μmol/L)]
Mean ± Standard Deviation
  7.521  ± 2.6229  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  63.08  ± 9.912  
[1] Stage means how big the tumor is and how far it's spread. Stages range from 0 (the cancer has not spread beyond the inner lining of the lung) to IV (the cancer has spread to other organs of the body such as the other lung, brain, or liver).
[2] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
[3] N=32 (Data not available for 1 participant).
[4] N=25 (Data not available for 8 patients)



  Outcome Measures
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1.  Primary:   Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])   [ Time Frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]

2.  Secondary:   Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])   [ Time Frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]

3.  Secondary:   Overall Survival   [ Time Frame: baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment) ]

4.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]

5.  Secondary:   Duration of Response   [ Time Frame: time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]

6.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]

7.  Secondary:   Time to Tumor Progression   [ Time Frame: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment) ]


  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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00380718     History of Changes
Other Study ID Numbers: 10720, H3E-MC-JMIC
Study First Received: September 22, 2006
Results First Received: September 2, 2009
Last Updated: November 1, 2010
Health Authority: Taiwan: Department of Health