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FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Keith D Eaton, University of Washington
ClinicalTrials.gov Identifier:
NCT00564733
First received: November 27, 2007
Last updated: August 29, 2016
Last verified: August 2016
Results First Received: August 29, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Malignant Pleural Effusion
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions: Drug: carboplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Other: imaging biomarker analysis

  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
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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
Chemotherapy

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.

carboplatin: Given IV

docetaxel: Given IV

gemcitabine hydrochloride: Given IV

paclitaxel: Given IV

computed tomography: Undergo FDG PET/CT

positron emission tomography: Undergo FDG PET/CT

fludeoxyglucose F 18: Given IV

imaging biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Chemotherapy
STARTED   55 
COMPLETED   46 
NOT COMPLETED   9 
Withdrawal by Subject                4 
Ineligible                5 



  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.
All patients that signed consent and received at least one dose of chemotherapy.

Reporting Groups
  Description
Chemotherapy

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.

carboplatin: Given IV

docetaxel: Given IV

gemcitabine hydrochloride: Given IV

paclitaxel: Given IV

computed tomography: Undergo FDG PET/CT

positron emission tomography: Undergo FDG PET/CT

fludeoxyglucose F 18: Given IV

imaging biomarker analysis: Correlative studies


Baseline Measures
   Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   28 
>=65 years   18 
Age 
[Units: Years]
Mean (Full Range)
 60 
 (48 to 78) 
Gender 
[Units: Participants]
 
Female   22 
Male   24 
Region of Enrollment 
[Units: Participants]
 
United States   46 


  Outcome Measures

1.  Primary:   Overall Response Rate (Patients That Achieve a CR or PR)   [ Time Frame: At the end of 4 cycles of treatment ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Keith D. Eaton, MD, PhD
Organization: University of Washington
phone: 2062886249
e-mail: kdeaton@uw.edu



Responsible Party: Keith D Eaton, University of Washington
ClinicalTrials.gov Identifier: NCT00564733     History of Changes
Other Study ID Numbers: 6566
NCI-2010-00606 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: November 27, 2007
Results First Received: August 29, 2016
Last Updated: August 29, 2016
Health Authority: United States: Federal Government