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.

Cancer Categories

Lung

Karmanos Trial ID

2014-002

NCT ID

NCT02178163

Age Group

Adult

Scope

Local

Phase

Phase II

Principal Investigator

Gerold
Bepler, M.D., Ph.D. View Profile

Objective:

Primary:: 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:

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Eligibility

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

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at McLaren Bay Region

3140 W Campus Dr.
Bay City, MI 48706
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Phone: 989-667-2370

Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

1221 South Drive
Mount Pleasant, MI 48858
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Phone: 989-772-6811

Karmanos Cancer Institute at McLaren Clarkston

5680 Bow Pointe Dr
Clarkston, MI 48346
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Phone: 248-922-6650

Karmanos Cancer Institute at McLaren Flint

4100 Beecher Rd
Flint, MI 48532
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Phone: 810-342-3800

Karmanos Cancer Institute at McLaren Greater Lansing - Medical Oncology and Hematology

3520 Forest Rd.
Lansing, MI 48910
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Phone: 517-975-9500

Karmanos Cancer Institute at McLaren Lapeer Region

1295 Barry Drive
Lapeer, MI 48446
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Phone: 800-527-6266

Karmanos Cancer Institute at McLaren Macomb

1080 Harrington Blvd
Mount Clemens, MI 48043
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Phone: 586-493-7510

Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

560 W Mitchell St
Petoskey, MI 49770
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Phone: 231-487-3390

Karmanos Cancer Institute at McLaren Port Huron

1221 Pine Grove Ave
Port Huron, MI 48060
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Phone: 810-982-5200

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices