FDG-PET/CT Scans in Patients With Stage IIIB or Stage IV NSCLC Undergoing Chemotherapy

• Status: Terminated
• Trial end date: 0000-00-00
• Target enrollment: 96
• Participant gender: Both

Summary

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET)/CT scans, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying ^18FDG PET/CT scans to see how well they predict response in patients undergoing chemotherapy for stage IIIB or stage IV non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American College of Radiology Imaging Network
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluorodeoxyglucose F18
• Last Updated: 2013-02-04

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Newly diagnosed stage IIIB (with malignant pleural effusion) or stage IV disease (Group I and II), or newly diagnosed stage IIIA, IIIB, or IV (Group III) determined by all of the following:

• CT scan or MRI of the chest and upper abdomen (including liver and adrenal glands) within the past 4 weeks

• History/physical examination within the past 6 weeks

• CT scan or MRI of the brain within the past 4 weeks, if there is headache, mental/physical impairment, or other signs or symptoms suggesting brain metastases within the past 2 months

• No small cell carcinoma

• No pure bronchioloalveolar carcinoma

• Patients with recurrent or metastatic disease are eligible provided they meet 1 of the following criteria:

• Received surgery or radiotherapy for treatment of the primary tumor and locoregional disease ≥ 3 months prior to study entry AND have a measurable lesion in the chest

• Received chemotherapy in the adjuvant setting or as part of combined modality therapy for locoregional disease ≥ 3 months prior to recurrent or metastatic disease diagnosis AND have a measurable lesion in the chest

• Measurable disease, defined as at least 1 measurable primary tumor or other intrathoracic/supraclavicular lesion ≥ 2 cm

• Scheduled to be treated with a platinum-based dual-agent chemotherapy regimen administered at 3-week intervals with or without bevacizumab or cetuximab (Group I and II)

• Scheduled to be treated with standard chemotherapy in the current protocol, other standard chemotherapy, experimental chemotherapy, or other treatment including no treatment (Group III)

• No symptomatic brain metastases (Groups I and II only)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2 (Groups I and II only)

• Group III may include potential participants regardless of ECOG performance status score

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to tolerate positron emission tomography (PET)/CT scanning

• No contraindication to chemotherapy and PET/CT scanning, as demonstrated by laboratory testing

• No poorly controlled diabetes (i.e., fasting glucose level > 150 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications

• No prior malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma in situ, or other cancer from which the patient has been disease free for ≥ 3 years (Groups I and II)

• Prior malignancy is not an exclusion factor for Group III

• No clinical or radiographic signs of post-obstructive pneumonia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 3 months since prior thoracic radiotherapy, lung surgery, or chemotherapy

• Prior chemotherapy in the adjuvant setting or as part of a combined modality regimen for locoregional disease that was given ≥ 3 months prior to diagnosis of recurrent or metastatic disease allowed

• No planned treatment with any targeted biologic therapy including gefitinib or erlotinib hydrochloride (Group I and II)

• No concurrent chemoradiotherapy

• No concurrent bevacizumab