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Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00269152
First received: December 21, 2005
Last updated: July 15, 2014
Last verified: July 2014
Results First Received: November 12, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: pemetrexed
Drug: cisplatin
Drug: carboplatin

  Participant Flow


  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 + Cisplatin Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
Pemetrexed + Carboplatin Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
Total Total of all reporting groups

Baseline Measures
    Pemetrexed + Cisplatin     Pemetrexed + Carboplatin     Total  
Number of Participants  
[units: participants]
  63     59     122  
Age  
[units: years]
Mean ± Standard Deviation
  60.6  ± 7.7     58.9  ± 7.2     59.7  ± 7.5  
Gender  
[units: participants]
     
Female     14     18     32  
Male     49     41     90  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     62     58     120  
African     1     1     2  
Region of Enrollment  
[units: participants]
     
France     12     8     20  
Spain     7     8     15  
Germany     44     43     87  
Curative Surgery Used  
[units: participants]
     
Pneumonectomy     9     9     18  
Lobectomy     46     46     92  
Bi-lobectomy     8     4     12  
Smoking History  
[units: participants]
     
Yes     56     56     112  
No     7     3     10  
Stage of Disease Prior to Tumor Resection [1]
[units: participants]
     
Stage Ia     0     1     1  
Stage Ib     27     26     53  
Stage IIa     6     5     11  
Stage IIb     30     25     55  
Stage IIIa     0     1     1  
Unknown: could have been either Stage IIIb or IV     0     1     1  
Tumor Type at Initial Pathological Diagnosis  
[units: participants]
     
Adenocarcinoma of the Lung     27     23     50  
Squamous Carcinoma of the Lung     24     20     44  
Non-Small Cell Lung Cancer     5     4     9  
Mixed Cell (Squamous/Adeno) Carcinoma of Lung     0     5     5  
Large Cell Carcinoma of Lung     5     7     12  
Bronchoalveolar Carcinoma     2     0     2  
[1] Classification based on the American Joint Committee on Cancer Staging Criteria for Lung Cancer.



  Outcome Measures
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1.  Primary:   The Feasibility of Post-Surgery Chemotherapy   [ Time Frame: every 21-day cycle for 4 cycles up to 30 days after last infusion ]

2.  Secondary:   Grade III/IV Adverse Events   [ Time Frame: every 21-day cycle for 4 cycles ]

3.  Secondary:   Overall Survival at 3 Years   [ Time Frame: baseline to date of death from any cause, assessed at 3 years ]

4.  Secondary:   3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years   [ Time Frame: length of time disease free, assessed at 3 years ]

5.  Secondary:   Overall Survival at 6 Years   [ Time Frame: Baseline to date of death from any cause assessed at 6 years ]


  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
A protocol amendment was approved after the trial original completed to allow for collection of additional overall survival data due to number of participants surviving at 3 years.


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