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Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

This study has been terminated.
(Stopped early due to low enrollment)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00356525
First received: July 24, 2006
Last updated: August 9, 2010
Last verified: August 2010
History of Changes
Results First Received: June 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Neoplasms
Interventions: Drug: pemetrexed
Drug: gemcitabine
Drug: carboplatin
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
No text entered.

Reporting Groups
  Description
Less Than One Year: Pemetrexed Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Less Than One Year: Pemetrexed + Gemcitabine Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
One Year or Greater: Pemetrexed + Carboplatin Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
One Year or Greater: Pemetrexed + Gemcitabine Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression

Participant Flow:   Overall Study
    Less Than One Year: Pemetrexed     Less Than One Year: Pemetrexed + Gemcitabine     One Year or Greater: Pemetrexed + Carboplatin     One Year or Greater: Pemetrexed + Gemcitabine  
STARTED     14     11     7     9  
COMPLETED     0     0     0     0  
NOT COMPLETED     14     11     7     9  
Progressive Disease                 8                 5                 4                 2  
Adverse Event                 1                 3                 1                 1  
Lost to Follow-up                 1                 0                 0                 0  
Physician Decision                 2                 2                 2                 1  
Protocol Entry Criteria Not Met                 1                 0                 0                 0  
Withdrawal by Subject                 1                 1                 0                 3  
Death                 0                 0                 0                 1  
Sponsor Decision                 0                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Less Than One Year: Pemetrexed Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Less Than One Year: Pemetrexed + Gemcitabine Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
One Year or Greater: Pemetrexed + Carboplatin Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
One Year or Greater: Pemetrexed + Gemcitabine Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
Total Total of all reporting groups

Baseline Measures
    Less Than One Year: Pemetrexed     Less Than One Year: Pemetrexed + Gemcitabine     One Year or Greater: Pemetrexed + Carboplatin     One Year or Greater: Pemetrexed + Gemcitabine     Total  
Number of Participants  
[units: participants]
 		  14     11     7     9     41  
Age, Customized  
[units: participants]
 		         
<=65 years     6     3     2     4     15  
>65 years     8     8     5     5     26  
Gender  
[units: participants]
 		         
Female     6     6     0     4     16  
Male     8     5     7     5     25  
Region of Enrollment  
[units: participants]
 		         
United States     14     11     7     9     41  
Disease Stage at Initial Diagnosis [1]
[units: participants]
 		         
Stage IV     14     11     7     9     41  
Eastern Cooperative Oncology Group Performance Status [2]
[units: participants]
 		         
0 - Fully Active     6     3     2     6     17  
1 - Ambulatory, Restricted Strenuous Activity     8     8     5     3     24  
History of Brain Metastates  
[units: participants]
 		         
No     12     11     7     9     39  
Yes     2     0     0     0     2  
Prior Systemic Therapy [3]
[units: participants]
 		         
Adjuvant     12     11     6     9     38  
Neoadjuvant     3     0     1     1     5  
Race/Ethnicity  
[units: participants]
 		         
Black or African American     0     0     2     0     2  
East Asian     0     0     0     1     1  
West Asian     0     0     0     1     1  
Caucasian     14     11     5     7     37  
[1] Stages of disease range from 0 (no evidence of primary tumor) to IV (tumor in multiple locations).
[2] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).
[3] Participants could have more than one type of prior systemic therapy which may result in the total numbers per arm being larger than the overall number of participants per arm.



  Outcome Measures
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1.  Primary:   Objective Tumor Response   [ Time Frame: baseline to time of response (up to 17.5 months) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival   [ Time Frame: baseline to trial termination (17.5 months) ]
  Show Outcome Measure 2

3.  Secondary:   Time to Progressive Disease   [ Time Frame: baseline to measured progressive disease (up to 17.5 months) ]
  Show Outcome Measure 3

4.  Secondary:   Duration of Response   [ Time Frame: time of response to progressive disease (up to 17.5 months) ]
  Show Outcome Measure 4

5.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to stopping treatment (up to 17.5 months) ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Time to Treatment Failure
Measure Description No text entered.
Time Frame baseline to stopping treatment (up to 17.5 months)  
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.
Outcome measure was not analyzed due to insufficient data.

Reporting Groups
  Description
Less Than One Year: Pemetrexed Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Less Than One Year: Pemetrexed + Gemcitabine Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
One Year or Greater: Pemetrexed + Carboplatin Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
One Year or Greater: Pemetrexed + Gemcitabine Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression

Measured Values
    Less Than One Year: Pemetrexed     Less Than One Year: Pemetrexed + Gemcitabine     One Year or Greater: Pemetrexed + Carboplatin     One Year or Greater: Pemetrexed + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
 		  0     0     0     0  
Time to Treatment Failure  
[units: months]
Mean ± Standard Deviation 		               

No statistical analysis provided for Time to Treatment Failure




  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
The trial terminated early due to slow enrollment. Secondary outcomes were not analyzed due to insufficient data. Original results reported were interim analyses. Results have now been updated with final data.  


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: NCT00356525     History of Changes
Other Study ID Numbers: 9934, H3E-US-S082
Study First Received: July 24, 2006
Results First Received: June 8, 2009
Last Updated: August 9, 2010
Health Authority: United States: Food and Drug Administration