FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 courses of docetaxel/gemcitabine as measured by CT
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
At the end of 4 courses of treatment
No
Keith Eaton
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
6566
NCT00564733
October 2007
March 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Harborview Medical Center | Seattle, Washington 98104 |