Appointments

Submit a Form

Questions

Submit a Form

Cancer Answer Line:
866.223.8100

M-F 8 a.m. - 4:30 p.m. ET

Expand Content

View Cancer Clinical Trials

CASE 1Y13   |   13-545
Feasibility and clinical impact of next generation genomic sequencing in selected solid tumor patients

Disease(s)
Adrenal
Biliary
Bladder
Brain
Breast
Colorectal
Glioblastoma
Head & Neck
High Grade Glioma
Lung
Melanoma
Mesothelioma
Pancreas
Prostate
Renal
Hospital(s)
Main Campus
Phase(s)
Stage(s)
Type(s)
Drug(s)

Contact Information
Cancer Answer Line

866.223.8100

8:00 am - 4:30 pm, Monday - Friday


Description
Primary Aim
  1. To evaluate the feasibility of conducting genomic analyses on tumor tissues collected from solid tumor patients seen at the Cleveland Clinic. Feasibility will be defined as the proportion of patients signing consent who are able to have tumor tissue shipped to Foundation Medicine within 14 days of patient consent.
Secondary Aims
  1. To evaluate the time it takes for Foundation Medicine to provide results. We will evaluate what proportion of patients have a result delivered from Foundation Medicine within 21 days of shipment of sample to them.
  2. To analyze what proportion of genomic analyses yield actionable genetic aberrations, and what proportion lead to change in patient management plan. Actionable will be defined as a mutation linked to an approved therapy in the solid tumor under study or another solid tumor, a known or suspected contraindication to a given therapy, or a clinical trial linked to the alteration.
  3. To evaluate clinical outcomes of specific therapies chosen to target these aberrations. Standard clinical outcome measures (objective response rate, progression-free survival) will be captured.
  4. To evaluate the cost implications associated with this testing and subsequent treatment selection, compared with non-genomic-directed standard of care therapy.

Inclusion Criteria
  1. Solid tumor with a confirmed histopathologic diagnosis falling into one of the following categories and without a known curative therapeutic option:
    • Metastatic/locally-advanced carcinoma of unknown primary - this includes tumors in which the pathology reads poorly differentiated (adeno)carcinoma in which the primary organ site cannot be discerned with certainty despite adequate clinical, laboratory and radiologic investigations
    • Metastatic/locally-advanced non-small cell lung cancer in a non/light/distant smoker (less than 10 pack-years smoking history, or quit smoking more than 15 years prior) without known EGFR or EML4-ALK mutation in the tumor
    • Unresectable pancreatobiliary cancer
    • Head and neck squamous cell carcinoma, after failure of primary therapy
    • Metastatic/unresectable pleural mesothelioma
    • Metastatic breast cancer: either triple-negative-defined as ER-negative (<1%), PR-negative (<1%), HER2 non-amplified (IHC 0/1 or FISH ratio <2.0) at any line of therapy; or hormone receptor positive/HER2 negative that are endocrine therapy and/or chemotherapy resistant (progressed on more than 2 lines of endocrine therapy and/or more than 2 chemotherapy regimens in the metastatic setting)
    • Metastatic colorectal cancer
  2. Age ≥ 18 years
  3. ECOG performance status 0, 1 or 2
  4. Measurable and/or evaluable disease per RECIST version 1.1
  5. Prior therapies (e.g. chemotherapy, targeted therapy, surgery, radiation) are permitted but not required

Exclusion Criteria
Exclusion Criteria Not Available

Cancer Answers & Appointments

Speak with a cancer nurse specialist for appointment assistance and for answers to your questions about cancer locally at 216.444.7923 or toll-free 1.866.223.8100.

Monday through Friday from 8 a.m. – 4:30 p.m. (ET).

Referrals

Resources for medical professionals

  • Outpatient appointment referrals: 216.444.7923 or 866.223.8100
  • Inpatient hospital transfers: 800.553.5056
  • Referring Physician Concierge: 216.444.6196 or 216.312.4910.

Clinical Trials

Search available cancer clinical trials by disease, hospital, phase or number.

This information is provided by Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition.

© Copyright 2014 Cleveland Clinic. All rights reserved.