Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

This study has been terminated.
(Due to drug unavailability)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00281827
First received: January 24, 2006
Last updated: November 6, 2012
Last verified: November 2012
Results First Received: June 23, 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: Lung Cancer
Interventions: Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: thalidomide
Procedure: conventional surgery

  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
Patients were recruited from 3 participating study centers.

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
Intent-to-Treat Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).

Participant Flow:   Overall Study
    Intent-to-Treat  
STARTED     22  
COMPLETED     22 [1]
NOT COMPLETED     0  
[1] All patients received 3 cycles of therapy; 2 did not receive all 3 thalidomide cycles



  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
Intent-to-Treat Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).

Baseline Measures
    Intent-to-Treat  
Number of Participants  
[units: participants]
  22  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     19  
>=65 years     3  
Age  
[units: years]
Median ( Full Range )
  53  
  ( 32 to 78 )  
Gender  
[units: participants]
 
Female     12  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures
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1.  Primary:   Number of Patients Reporting Clinical Response   [ Time Frame: At end of 3 -21 day cycles of treatment ]

2.  Secondary:   Number of Patients Disease-free at 1 Year   [ Time Frame: 1 year ]

3.  Secondary:   Number of Patients Disease-free at 2 Years   [ Time Frame: 2 Years ]

4.  Secondary:   Number of Patients Alive at 1 Year (Survival)   [ Time Frame: 12 Months ]

5.  Secondary:   Number of Patients Alive at 2 Years (Survival)   [ Time Frame: 24 Months ]

6.  Secondary:   Number of Patients Alive at 56 Months (End of Study)   [ Time Frame: Up to 56 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Arkadiusz Dudek, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-624-0123
e-mail: dudek002@umn.edu


No publications provided


Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00281827     History of Changes
Other Study ID Numbers: 2002LS013, LILLY-X-382, 0202M17981
Study First Received: January 24, 2006
Results First Received: June 23, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration