FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00564733|
Recruitment Status : Completed
First Posted : November 28, 2007
Results First Posted : October 21, 2016
Last Update Posted : February 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Effusion Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer||Drug: carboplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: computed tomography Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Other: imaging biomarker analysis||Phase 2|
I. Assess the response rate in patients who do not demonstrate an early response to carboplatin/paclitaxel as determined by FDG-PET ("initial non-responders") who are subsequently treated with three additional courses of docetaxel/gemcitabine.
I. Evaluate the ability of FDG-PET to predict response to therapy as measured by computed tomography (CT).
II. Evaluate the early and late changes in tumor FDG uptake (change in standardized uptake value [SUV]) in all patients and correlate with overall survival (OS).
OUTLINE: All patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG-PET/CT scan between days 18-21.
Patients are then assigned to 1 of 2 treatment groups.
GROUP I (Responders): Patients 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.
GROUP II (Initial non-responders): Patients 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.
After completion of study treatment, patients are followed up at days 81-84 and then periodically thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||March 2012|
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT (fludeoxyglucose F 18 positron emission tomography/computed tomography) scan between days 18-21. The FDG PET/CT is an imaging biomarker analysis. Patients that are responding to treatment receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients that are not responding to chemotherapy per FDG PET 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. Non-responding patients undergo an additional FDG PET/CT scan between days 18-21 of course 2.
Other Names:Drug: docetaxel
Other Names:Drug: gemcitabine hydrochloride
Other Names:Drug: paclitaxel
Other Names:Procedure: computed tomography
Undergo FDG PET/CT
Other Name: tomography, computedProcedure: positron emission tomography
Undergo FDG PET/CT
Other Names:Radiation: fludeoxyglucose F 18
Other Names:Other: imaging biomarker analysis
- Overall Response Rate (Patients That Achieve a CR or PR) [ Time Frame: At the end of 4 cycles of treatment, up to 24 weeks. ]Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564733
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Keith Eaton||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|