NCT00564733

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

FDG-PET Based Chemotherapy Selection for Metastatic Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Malignant Pleural Effusion
• Stage IIIB Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	Given IV
DRUG	docetaxel	Given IV
DRUG	gemcitabine hydrochloride	Given IV
DRUG	paclitaxel	Given IV
PROCEDURE	computed tomography	Undergo FDG PET/CT
PROCEDURE	positron emission tomography	Undergo FDG PET/CT
RADIATION	fludeoxyglucose F 18	Given IV
OTHER	imaging biomarker analysis	Correlative studies

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2007-11-28
• Last updated: 2017-02-10
• Results posted: 2016-10-21

Locations

2 sites across 1 country: United States