Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer
This phase II trial studies how well fludeoxyglucose F 18 (FDG)-labeled positron emission tomography (PET) scan works in planning chemotherapy in treating patients with stage IIIB or IV non-small cell lung cancer (NSCLC). Drugs used in chemotherapy, such as paclitaxel, carboplatin, gemcitabine hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Diagnostic imaging procedures, such as FDG-labeled PET scan, may help in guiding chemotherapy and allow doctors to plan better treatment
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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