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

NCT00564733 | Completed Phase 2 Results

• 3 other identifiers: 6566NCI-2010-006065R21CA123866-02
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Patients That Achieve a CR or PR)

  Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  At the end of 4 cycles of treatment, up to 24 weeks.

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT (fludeoxyglucose F 18 positron emission tomography/computed tomography) scan between days 18-21. The FDG PET/CT is an imaging biomarker analysis. Patients that are responding to treatment receive paclitaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients that are not responding to chemotherapy per FDG PET then 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. Non-responding patients undergo an additional FDG PET/CT scan between days 18-21 of course 2.

Drug: carboplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Procedure: computed tomography; Procedure: positron emission tomography; Radiation: fludeoxyglucose F 18; Other: imaging biomarker analysis

Interventions

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Chemotherapy

docetaxel DRUG

Given IV

Also known as: RP 56976, Taxotere, TXT

Chemotherapy

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Chemotherapy

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Chemotherapy

computed tomography PROCEDURE

Undergo FDG PET/CT

Also known as: tomography, computed

Chemotherapy

positron emission tomography PROCEDURE

Undergo FDG PET/CT

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Chemotherapy

fludeoxyglucose F 18 RADIATION

Given IV

Also known as: 18FDG, FDG

Chemotherapy

imaging biomarker analysis OTHER

Correlative studies

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients must have baseline FDG-PET and CT scans performed at the University of Washington (UW)/Seattle Cancer Care Alliance (SCCA) within two weeks from the start of chemotherapy
• Asymptomatic patients with clinically stable brain metastases (treated or untreated) are allowed
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) throughout treatment and for 30 days following the last dose of chemotherapy
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• 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
• Patients with a detectable second malignancy are excluded, as this could confound tumor evaluation and affect patient survival
• Patients who are likely to need palliative radiation therapy for painful bony metastases, impending fractures, or hemoptysis

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Docetaxel; Gemcitabine; Paclitaxel; Taxes; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Lung Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Keith D. Eaton, MD, PhD
• Organization: University of Washington

kdeaton@uw.edu

2062886249

Study Officials

• Keith Eaton

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 28, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 10, 2017
• Results First Posted: October 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)