We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408460
First Posted: December 7, 2006
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Renato Martins, University of Washington
Results First Submitted: January 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Malignant Pleural Effusion
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions: Drug: imatinib mesylate
Drug: paclitaxel

  Participant Flow
  Hide 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 that were aged 70 years and above that had never received treatment for metastatic NSCLC were approached for study participation.

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
Treatment (Enzyme Inhibitor, Chemotherapy)

Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

imatinib mesylate: Given PO

paclitaxel: Given IV

immunohistochemistry staining method: Optional correlative studies


Participant Flow:   Overall Study
    Treatment (Enzyme Inhibitor, Chemotherapy)
STARTED   34 
COMPLETED   34 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide 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
Treatment (Enzyme Inhibitor, Chemotherapy)

Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

imatinib mesylate: Given PO

paclitaxel: Given IV

immunohistochemistry staining method: Optional correlative studies


Baseline Measures
   Treatment (Enzyme Inhibitor, Chemotherapy) 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      34 100.0% 
Age 
[Units: Years]
Median (Full Range)
 75 
 (70 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  32.4% 
Male      23  67.6% 
Region of Enrollment 
[Units: Participants]
 
United States   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria   [ Time Frame: Baseline, Week 4 of courses 2, 4 and 6 ]

2.  Secondary:   Time to Tumor Progression   [ Time Frame: Baseline and every 2 months post treatment until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed up to 5 years. ]

3.  Secondary:   Overall Survival   [ Time Frame: Every 3 months for 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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


Results Point of Contact:  
Name/Title: Renato G Martins, MD
Organization: University of Washington
phone: 206-288-2048
e-mail: rgmart@uw.edu



Responsible Party: Renato Martins, University of Washington
ClinicalTrials.gov Identifier: NCT00408460     History of Changes
Other Study ID Numbers: 6137
NCI-2010-00420 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: January 17, 2017
Results First Posted: April 25, 2017
Last Update Posted: April 25, 2017