Phase
Condition
Pleural Effusion
Lung Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologically or cytologically confirmed NSCLC; patients must havestage IIIB with malignant pleural effusion or with nodal disease so extensive that itis not amenable to radiotherapy with curative intent, or stage IV disease, as definedby 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 beaccurately 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 xbackground and SUV > 3
All patients must not have received treatment with conventional cytotoxic chemotherapyfor NSCLC; patients may have had prior radiotherapy or may have been treated with theepidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) (i.e.erlotinib or gefitinib); one week must have elapsed after discontinuation, prior tothe initial PET scan for patients previously treated with a TKI; patients who receiveradiotherapy 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 patientswith creatinine levels above institutional normal
Patients must have baseline FDG-PET and CT scans performed at the University ofWashington (UW)/Seattle Cancer Care Alliance (SCCA) within two weeks from the start ofchemotherapy
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
Exclusion
Exclusion Criteria:
Patients who have received EGFR TKI (i.e. erlotinib or gefitinib) within one weekprior to entering the study
Patients may not be receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologiccomposition agents used in the study
Inability or unwillingness to take corticosteroids, which are required pre-medicationsfor 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 thepaclitaxel and docetaxel have potential for neurotoxicity
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements
Pregnant or breastfeeding women
Patients with a detectable second malignancy are excluded, as this could confoundtumor evaluation and affect patient survival
Patients who are likely to need palliative radiation therapy for painful bonymetastases, impending fractures, or hemoptysis
Study Design
Study Description
Connect with a study center
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington 98109
United StatesSite Not Available
Harborview Medical Center
Seattle, Washington 98104
United StatesSite Not Available

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