Clinical trial NCT02566421: Genomic Sequencing in Determining Treatment in Patients With Metastatic Cancer or Cancer That Cannot Be Removed by Surgery
Official title: Precision Medicine for Patients With Malignancy at the Comprehensive Cancer Center of Wake Forest University
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the feasibility of implementing a Precision Oncology protocol in the treatment of patients who undergo genomic sequencing.

SECONDARY OBJECTIVES:

I. To determine treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment.

II. To assess survival in patients who receive targeted treatment versus those who do not receive targeted treatment.

III. To assess changes in patient-reported outcomes in patients who receive targeted treatment versus those who do not receive targeted treatment.

IV. To perform exploratory statistical genetic and bioinformatics analyses using the data derived from the genomic sequencing to catalogue additional important variants and determine whether there are any patterns or associations among patient level risk factors, their outcomes and genomic information that was not identified by the original genomic sequencing analyses.

OUTLINE:

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

After completion of study treatment, patients are followed up every 2 months.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility in terms of the ability to monitoring patient outcomes across separate treatment protocols and study teams.
timeFrame: Up to 2 years
measure: Proportion of patients enrolled on this protocol who are subsequently enrolled in a clinical trial based on the results of the genomic sequencing
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Proportion of patients with an actionable mutation
timeFrame: Baseline
measure: Feasibility in terms of the ability to monitoring patient adverse events across separate treatment protocols and study teams.
timeFrame: Up to 2 years
Secondary outcomes:
measure: Change in patient-reported symptoms of cancer and cancer treatment, as assessed by the MD Anderson Symptom Inventory
timeFrame: Baseline to up to 48 weeks
measure: Patient's perceived quality care, as assessed by 3 items adapted from Arora, et al
timeFrame: Up to up to 48 weeks
measure: Patient's satisfaction with treatment decision-making and decisional regret, as assessed by an adapted Satisfaction with Decision scale
timeFrame: Up to up to 48 weeks
measure: 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
timeFrame: Up to up to 48 weeks
measure: Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment
timeFrame: Up to 6 months
measure: Survival rate in patients who receive targeted treatment versus those who do not receive targeted treatment
timeFrame: Up to 12 months
measure: Treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment
timeFrame: Up to 2 years
Other outcomes:
measure: Genetic variant data
timeFrame: Up to 2 years
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Angela Alistar
role: PRINCIPAL_INVESTIGATOR
References: