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Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00906282
First received: May 19, 2009
Last updated: January 5, 2017
Last verified: January 2017
Results First Received: November 7, 2016  
Study Type: Interventional
Study Design: 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
Between Aug 2009 and Jul 2013, 46 patients with potentially resectable non-squamous NSCLC were enrolled from 10 participating sites in the U.S.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients (pts) received up to 4 cycles (12 weeks) of preoperative chemotherapy and were restaged after 6 and 12 weeks. Pts with progressive disease or intolerable toxicity came off study; pts who remained surgical candidates had resection at weeks 15-18. Following resection pts received no further planned protocol treatment.

Reporting Groups
  Description
Pemetrexed/Carboplatin/Surgery

Up to 12 weeks of preoperative chemotherapy:

  • Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;
  • Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle

Weeks 15-18: Patients deemed surgical candidates will have resection.


Participant Flow for 2 periods

Period 1:   Preoperative Chemotherapy
    Pemetrexed/Carboplatin/Surgery
STARTED   46 
COMPLETED   27 [1] 
NOT COMPLETED   19 
Withdrawal by Subject                2 
Not surgical candidates, off study                10 
Progressive disease                6 
Toxicity                1 
[1] 2 of 27 patients completed less than 4 cycles and were deemed surgical candidates.

Period 2:   Surgical Resection
    Pemetrexed/Carboplatin/Surgery
STARTED   27 
COMPLETED   27 
NOT COMPLETED   0 



  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/Carboplatin/Surgery

Up to 12 weeks (4 cycles) of preoperative treatment given on Day 1 of each 21-day cycle:

  • Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes
  • Carboplatin: AUC 6.0, IV infused over 30-60 minutes

At weeks 15-18, surgical candidates will have resection.


Baseline Measures
   Pemetrexed/Carboplatin/Surgery 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Median (Full Range)
 65 
 (42 to 82) 
Gender 
[Units: Participants]
Count of Participants
 
Female      28  60.9% 
Male      18  39.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Caucasian   42 
African-American   4 
Region of Enrollment 
[Units: Participants]
 
United States   46 
Clinical Stage of Cancer [1] 
[Units: Participants]
 
Stage 1B   5 
Stage IIA/II/B   17 
Stage IIIA   23 
Stage IIIB   1 
[1] Number of patients based on clinical stage of disease at study entry.


  Outcome Measures
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1.  Primary:   3-Year Overall Survival Rate   [ Time Frame: 36 months ]

2.  Secondary:   Objective Tumor Response   [ Time Frame: At 6 and 12 weeks ]

3.  Secondary:   Pathologic Response Rate   [ Time Frame: weeks 15 -18 ]

4.  Secondary:   Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)   [ Time Frame: At 15-18 weeks ]

5.  Secondary:   Complete Resection Rate   [ Time Frame: At weeks 15-18 ]


  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
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Charles Davis, RAC
Organization: SCRI Development Innovations
phone: 615-524-4341
e-mail: charles.davis2@scri-innovations.com



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00906282     History of Changes
Other Study ID Numbers: SCRI LUN 186
Study First Received: May 19, 2009
Results First Received: November 7, 2016
Last Updated: January 5, 2017