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

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ClinicalTrials.gov Identifier: NCT00281827
Recruitment Status : Terminated (Due to drug unavailability)
First Posted : January 25, 2006
Results First Posted : December 3, 2009
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: thalidomide
Procedure: conventional surgery

  Participant Flow

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
No text entered.

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

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 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      19  86.4% 
>=65 years      3  13.6% 
Age 
[Units: Years]
Median (Full Range)
 53 
 (32 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  54.5% 
Male      10  45.5% 
Region of Enrollment 
[Units: Participants]
 
United States   22 


  Outcome Measures

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

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

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



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00281827     History of Changes
Other Study ID Numbers: 2002LS013
LILLY-X-382 ( Other Identifier: Eli Lilly )
0202M17981 ( Other Identifier: IRB, University of Minnesota )
First Submitted: January 24, 2006
First Posted: January 25, 2006
Results First Submitted: June 23, 2009
Results First Posted: December 3, 2009
Last Update Posted: December 28, 2017