RecruitingNot ApplicableNCT02178163
Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer
A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.
Sponsor
Barbara Ann Karmanos Cancer Institute
Enrollment
1,020 participants
Start Date
Aug 1, 2014
Study Type
INTERVENTIONAL
Conditions
Summary
This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid \[DNA\]) and help doctors to tailor treatment to target the specific mutations.
Eligibility
Min Age: 18 Years
Inclusion Criteria11
- Stage IV or recurrent Non-Small Cell Lung Cancer patients who either have archival tissue for genomic analysis or are willing to undergo a new biopsy to obtain tumor tissue for genomic analysis. Patients whose tumor has already undergone genomic analysis 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) or calculated creatinine clearance (Cockcroft-Gault formula) of \> 45 mL/min
- Serum bilirubin =\< 1.5 X ULN
- Transaminases (serum glutamic oxaloacetic transaminase \[SGOT\] and/or serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 times institutional ULN and alkaline phosphatase =\< 2.5 times ULN, unless patient has liver metastases and the managing physician believes that the elevation in liver enzymes is only related to the liver metastases
- 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 biopsy specimen can be an already obtained diagnostic specimen provided the patient has not received 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 that has been radiated.
- Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines
Exclusion Criteria3
- Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
- Serious medical illness including but not limited to uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction or cerebrovascular event with 6 months of registration, history of chronic active hepatitis or history of human immunodeficiency virus (HIV) or an active bacterial infection will not be eligible
- Pregnant or lactating women; female patients of child bearing potential will be informed that if they do enroll on a therapeutic trial, based on the genomic analyses, that they may not be able to enroll on a clinical trial if they are pregnant; all sexually active patients will be informed that patients enrolling on a therapeutic trial have to use contraceptive methods to prevent pregnancy
Interventions
OTHERcytology specimen collection procedure
Correlative studies
OTHERlaboratory biomarker analysis
Correlative studies
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT02178163