Phase
Condition
N/ATreatment
cytology specimen collection procedure
laboratory biomarker analysis
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archivaltissue for genomic analysis or are willing to undergo a new biopsy to obtain tumortissue for genomic analysis. Patients whose tumor has already undergone genomicanalysis will be eligible.
Zubrod performance status 0-2
Life expectancy >= 3 months
Absolute neutrophil count of > 1.5 x 10^9/L
Platelet count > 100,000 x 10^9/L
Serum creatinine =< 1.5 times the institutional upper limit of normal (ULN) orcalculated creatinine clearance (Cockcroft-Gault formula) of > 45 mL/min
Serum bilirubin =< 1.5 X ULN
Transaminases (serum glutamic oxaloacetic transaminase [SGOT] and/or serum glutamatepyruvate transaminase [SGPT]) =< 2.5 times institutional ULN and alkalinephosphatase =< 2.5 times ULN, unless patient has liver metastases and the managingphysician believes that the elevation in liver enzymes is only related to the livermetastases
Laboratory tests should be done within 30 days of enrollment on the trial
A biopsy of the patient's tumor for genomic profiling is required; this biopsyspecimen can be an already obtained diagnostic specimen provided the patient has notreceived systemic therapy since the biopsy has been obtained and was obtained within 60 days of trial enrollment. The biopsy material cannot be from a tumor site thathas been radiated.
Signed informed consent that details the investigational nature of the studyaccording to institutional and federal guidelines
Exclusion
Exclusion Criteria:
Patients with concurrent malignancy; patients with prior or concurrent malignancywill be allowed as long as the treating physician considers it unlikely to impactthe clinical outcome of the patient
Serious medical illness including but not limited to uncontrolled congestive heartfailure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6months of registration, history of chronic active hepatitis or history of humanimmunodeficiency virus (HIV) or an active bacterial infection will not be eligible
Pregnant or lactating women; female patients of child bearing potential will beinformed that if they do enroll on a therapeutic trial, based on the genomicanalyses, that they may not be able to enroll on a clinical trial if they arepregnant; all sexually active patients will be informed that patients enrolling on atherapeutic trial have to use contraceptive methods to prevent pregnancy
Study Design
Study Description
Connect with a study center
KCI at McLaren Bay Region
Bay City, Michigan 48708
United StatesActive - Recruiting
KCI at Mclaren Bloomfield Hills
Bloomfield Hills, Michigan 48302
United StatesActive - Recruiting
KCI At McLaren Clarkston
Clarkston, Michigan 48346
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
KCI at McLaren Flint
Flint, Michigan 48532
United StatesActive - Recruiting
KCI at McLaren Greater Lansing, Mid Michigan Physicians
Lansing, Michigan 48910
United StatesActive - Recruiting
KCI at McLaren Lapeer Region
Lapeer, Michigan 48446
United StatesActive - Recruiting
KCI at McLaren Macomb
Mount Clemens, Michigan 48043
United StatesActive - Recruiting
KCI at McLaren Central Michigan
Mount Pleasant, Michigan 48858
United StatesActive - Recruiting
KCI at Northern Michigan
Petoskey, Michigan 49770
United StatesActive - Recruiting
KCI at Northern Michigan Petoskey
Petoskey, Michigan 49770
United StatesActive - Recruiting
KCI at McLaren Port Huron
Port Huron, Michigan 48060
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.