Lung Cancer Clinical Trial

Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

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.

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Full Description

PRIMARY OBJECTIVES:

I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens.

SECONDARY OBJECTIVES:

I. To estimate the percentage of patients in whom genomic analysis can be performed.

II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results.

OUTLINE:

Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

96

Study ID:

NCT02178163

Recruitment Status:

Recruiting

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There are 3 Locations for this study

See Locations Near You

KCI at McLaren Bay Region
Bay City Michigan, 48708, United States More Info
Contact
800-527-6266
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Gerold Bepler, M.D.
Contact
800-527-6266
[email protected]
Gerold Bepler, M.D., PhD.
Principal Investigator
Ammar Sukari, M.D.
Sub-Investigator
Hirva Mamdani, M.D.
Sub-Investigator
Alicia Bolling-Fischer, M.D.
Sub-Investigator
Fulvio Lonardo, M.D.
Sub-Investigator
Jonathan D. Abramson, M.D.
Sub-Investigator
Shalini Thoutreddy, M.D.
Sub-Investigator
Samir Alsawah, M.D.
Sub-Investigator
Maden Arora, M.D.
Sub-Investigator
Sai Bikkina, M.D.
Sub-Investigator
Rana Bilbeisi, M.D,
Sub-Investigator
Aliccia Bollig-Fischer, M.D.
Sub-Investigator
Elena Coppola, M.D.
Sub-Investigator
Salman Fateh, M.D.
Sub-Investigator
Sandeep Grewal, M.D.
Sub-Investigator
Youssef Hanna, M.D.
Sub-Investigator
Christian Hyde, M.D.
Sub-Investigator
Frank Knechtl, M.D.
Sub-Investigator
Cheryl Kovalski, M.D.
Sub-Investigator
Elizabeth Layhe, M.D.
Sub-Investigator
Stephanie Leslie, M.D.
Sub-Investigator
Sharon Levandowski, M.D.
Sub-Investigator
Mohammed Masri, M.D.
Sub-Investigator
Seraphim Pallas, M.D.
Sub-Investigator
Trevor Singh, M.D.
Sub-Investigator
David Eilender, M.D.
Sub-Investigator
KCI at McLaren Port Huron
Port Huron Michigan, 48060, United States More Info
Contact
800-527-6266

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

96

Study ID:

NCT02178163

Recruitment Status:

Recruiting

Sponsor:


Barbara Ann Karmanos Cancer Institute

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