Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery

NCT02566421 | Terminated

• 5 other identifiers: IRB00033598NCI-2015-01373CCCWFU 01615CCCWFU # 01615P30CA012197
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies patients' genomic sequencing in determining specific treatments, also called Precision Medicine, in patients with cancer that has spread to other parts of the body (metastatic) and/or cannot be removed by surgery. Examining the genetic code of a patient's tumor, a mutation (a change in the deoxyribonucleic acid \[DNA\] sequence of a cell or gene) may be identified and matched with available treatment that targets the mutated gene or an alternative treatment that may provide benefit for the patient with the mutation identified. Precision medicine may impacts patient's response to treatment by targeting specific mutations and may increase survival and improve quality of life.

Conditions

Metastatic Neoplasm; Recurrent Neoplasm; Recurrent Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer; Unresectable Malignant Neoplasm

Outcome Measures

Primary Outcomes (5)

• Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams.

  Typical patient outcome measures will necessarily vary by disease, so survival will be the overarching outcome measure.

  Up to 2 years

• Proportion of patients enrolled on this protocol who are subsequently enrolled in a clinical trial based on the results of the genomic sequencing

  Baseline

• Proportion of patients enrolled on this protocol who have a clinical trial identified for them to be enrolled in based on the results of the genomic sequencing

  The observed proportion and corresponding 95% confidence intervals will be estimated.

  Baseline

• Proportion of patients with an actionable mutation

  Each patient enrolled will be dichotomized into either having a clinical trial identified (yes/no) that the results of their genomic sequencing suggests. The observed proportion and corresponding 95% confidence intervals will be estimated.

  Baseline

• Feasibility in terms of the ability to monitoring patient adverse events across separate treatment protocols and study teams.

  Up to 2 years

Secondary Outcomes (7)

• Change in patient-reported symptoms of cancer and cancer treatment, as assessed by the MD Anderson Symptom Inventory

  Baseline to up to 48 weeks

• Patient's perceived quality care, as assessed by 3 items adapted from Arora, et al

  Up to up to 48 weeks

• Patient's satisfaction with treatment decision-making and decisional regret, as assessed by an adapted Satisfaction with Decision scale

  Up to up to 48 weeks

• Self-perceived burden, as assessed by the Self-Perceived Burden Scale-Short form for measuring chronic disease patients' feelings of being a burden on their caregivers

  Up to up to 48 weeks

• Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment

  Up to 6 months

Other Outcomes (1)

• Genetic variant data

  Up to 2 years

Study Arms (1)

Treatment (precision medicine)

EXPERIMENTAL

Patients receive treatment based on the results of their genomic sequencing analyses.

Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Targeted Therapy

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (precision medicine)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (precision medicine)

Targeted Therapy OTHER

Receive treatment based on genomic sequencing

Treatment (precision medicine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unresectable cancer for which there are genomic drivers with corresponding Food and Drug Administration (FDA) approved or experimental drugs available, e.g. non-small cell lung cancer; and/or patients with histologically confirmed metastatic malignancy that have failed standard treatment or cannot tolerate standard treatment as deemed by the treating physician
• Malignancy must be measureable as per appropriate guidelines
• Patients who are willing to provide a specimen for genomic sequencing
• Preferred method:
• Tumor cell sample available and of sufficient quantity in the Tumor Tissue Shared Resource or patients who are willing to undergo additional tissue collection for tumor genomic sequencing through FoundationOne; available specimens must have been harvested within two years to be eligible
• Alternative method:
• Patients who are unwilling or unable to provide a tumor tissue sample and who undergoes Guardant360 sequencing may be considered eligible by the treating physician
• Patients who have already had their specimens sent for genomic sequencing are eligible provided they have not received their sequencing results at the time of enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Absence of clinically relevant liver or kidney failure as deemed by the treating physician
• Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diminished mental capacity or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnancy or lactation

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Angela Alistar

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: October 2, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (1)