Trials / Completed

CompletedNCT00963807

A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC

Phase II Single-Arm Trial Comparing the Use of FLT PET to Standard Computed Tomography to Assess the Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable Non-small Cell Lung Cancer

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 26 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 19 Years
Healthy volunteers: Not accepted

Summary

This study is being done to compare a special type of Positron Emission Tomography (PET) scan with CT scan in patients with surgically removable lung cancer to see which method is more useful in measuring a response to treatment. A PET scan uses small amounts of radioactive material injected into the blood to show the internal workings of the body. In this study, we will use two radioactive materials: 18F-FLT (referred to as FLT) and 18F-FDG (referred to as FDG). FDG is used routinely in the staging of lung cancer and is approved by the FDA for that purpose. FLT is used in the special type of PET scan being assessed by this study. In addition the study will assess the effects of the combination of docetaxel and cisplatin (chemotherapeutic drugs) on certain pathological characteristics of the tumor. The combination of docetaxel and cisplatin is approved by the Food and Drug Administration (FDA) for the treatment of advanced/metastatic NSCLC (non-small cell lung cancer). It is not approved for use in patients who have surgically removable NSCLC. In such cases cisplatin is used as a single drug therapy before surgery. The FDA is allowing the use of docetaxel along with cisplatin in this research study.

Detailed description

PRIMARY OBJECTIVES: I. To determine if the absolute decrease measured in primary tumor 18 F-F-3'-fluoro-3'-deoxy-L-thymidine (FLT) uptake (standard uptake value \[SUV\] and influx constant \[Ki\]) between pre-treatment imaging and imaging after the first cycle of therapy differs in patients categorized as responders or non-responders based on Response Evaluation Criteria in Solid Tumors (RECIST) measured with computed tomography (CT) after the second cycle of therapy. SECONDARY OBJECTIVES: I. To determine if the absolute decrease measured in primary tumor FDG uptake (SUV) between pre-treatment imaging and imaging after the first cycle of therapy differs in patients categorized as responders or non-responders based on RECIST measured with CT after the second cycle of therapy. II. To assess the effects of the combination of docetaxel and cisplatin on fractional tumor viability and proliferative fraction pre and post treatment and to correlate these with the PET SUV data for both tracers. III. To assess the methylation status of the checkpoint with forkhead and ring finger domains gene (CHFR) gene from pre-treatment tumor biopsies and correlate methylation status post treatment with clinical and pathologic response. OUTLINE: Patients receive docetaxel intravenously (IV) and cisplatin IV on day 1 and dexamethasone orally (PO) twice daily (BID). Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery. After completion of study treatment, patients are followed up for 4-6 weeks.

Conditions

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
PROCEDURE	CT	Undergo FDG PET/CT, FLT PET/CT and thoracic CT
DRUG	Docetaxel	Given IV
DRUG	FDG	Undergo FDG PET/CT
DRUG	FLT	Undergo FLT PET/CT
PROCEDURE	PET/CT	Undergo FDG PET/CT and FLT PET/CT
PROCEDURE	Surgery	Undergo surgery

Timeline

Start date: 2009-09-01
Primary completion: 2012-08-01
Completion: 2014-11-01
First posted: 2009-08-24
Last updated: 2017-03-17
Results posted: 2017-03-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00963807. Inclusion in this directory is not an endorsement.