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COMPLETEDPHASE2

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

NCT00564733•University of Washington

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed NSCLC; patients must have stage IIIB with malignant pleural effusion or with nodal disease so extensive that it is not amenable to radiotherapy with curative intent, or stage IV disease, as defined by the American Joint Committee on Cancer (AJCC) cancer staging handbook, 6th Edition (2002)
•Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (\>= 10 mm with spiral CT scan); patients' baseline FDG-PET scan must demonstrate a target lesion with SUV \>= 2 x background and SUV \> 3
•All patients must not have received treatment with conventional cytotoxic chemotherapy for NSCLC; patients may have had prior radiotherapy or may have been treated with the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) (i.e. erlotinib or gefitinib); one week must have elapsed after discontinuation, prior to the initial PET scan for patients previously treated with a TKI; patients who receive radiotherapy must have recovered from the side effects of therapy (except alopecia) and have measurable disease (target lesion) outside of the radiation field
•Life expectancy \>= 3 months
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
•Absolute neutrophil count \>= 1,500/mcL
•Platelets \>= 100,000/mcL
•Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
•Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 2 x institutional ULN (\< 5 x ULN for patients with liver metastases)
•Creatinine =\< 1.5 x ULN OR creatinine clearance \>= 40 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
+4 more criteria

Exclusion Criteria

•Patients who have received EGFR TKI (i.e. erlotinib or gefitinib) within one week prior to entering the study
•Patients may not be receiving any other investigational agents
•History of allergic reactions attributed to compounds of similar chemical or biologic composition agents used in the study
•Inability or unwillingness to take corticosteroids, which are required pre-medications for the chemotherapies in this trial
•Diabetes requiring insulin for management
•Patients must weigh less than 400 lbs
•Patients with post-obstructive pneumonia or lobar collapse
•Significant neuropathy (common toxicity criteria \[CTC\] grade \> 2), as both the paclitaxel and docetaxel have potential for neurotoxicity
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant or breastfeeding women
+2 more criteria

Locations (2)

Harborview Medical Center

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

September 1, 2011

Completion Date

March 1, 2012

Last Updated

February 10, 2017

Enrollment

ACTUAL participants

Conditions

Malignant Pleural EffusionStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Interventions

carboplatin

DRUG

docetaxel

DRUG

gemcitabine hydrochloride

DRUG

paclitaxel

DRUG

computed tomography

PROCEDURE

positron emission tomography

PROCEDURE

fludeoxyglucose F 18

RADIATION

imaging biomarker analysis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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