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

Primary Purpose

Metastatic Neoplasm, Recurrent Neoplasm, Recurrent Non-Small Cell Lung Carcinoma

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Targeted Therapy

About this trial

This is an interventional treatment trial for Metastatic Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Comprehensive Cancer Center of Wake Forest University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (precision medicine)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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

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.

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.

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

Secondary Outcome Measures

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

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

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

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

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

Kaplan Meier curves will be estimated and groups will be compared using Log-Rank tests. These analyses will be performed across all disease sites and then stratified by disease site.

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

Kaplan Meier curves will be estimated and groups will be compared using Log-Rank tests. These analyses will be performed across all disease sites and then stratified by disease site.

Treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment

For each patient a clinical response assessment will be ascertained and compared between groups. 95% confidence intervals will be estimated for the response rates (with stable disease [SD], partial response [PR] and complete response [CR] pooled together) and the repeated with PR and CR pooled together.

Full Information

NCT ID

NCT02566421

First Posted

September 14, 2015

Last Updated

June 29, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02566421

Brief Title

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

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Terminated

Why Stopped

Assessing Feasibility

Study Start Date

October 2015 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (precision medicine)

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Targeted Therapy

Intervention Description

Receive treatment based on genomic sequencing

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Up to 2 years

Title

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

Time Frame

Baseline

Title

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

Description

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

Time Frame

Baseline

Title

Proportion of patients with an actionable mutation

Description

Time Frame

Baseline

Title

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

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline to up to 48 weeks

Title

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

Time Frame

Up to up to 48 weeks

Title

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

Time Frame

Up to up to 48 weeks

Title

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

Time Frame

Up to up to 48 weeks

Title

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

Description

Kaplan Meier curves will be estimated and groups will be compared using Log-Rank tests. These analyses will be performed across all disease sites and then stratified by disease site.

Time Frame

Up to 6 months

Title

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

Description

Kaplan Meier curves will be estimated and groups will be compared using Log-Rank tests. These analyses will be performed across all disease sites and then stratified by disease site.

Time Frame

Up to 12 months

Title

Treatment response rates in patients who receive targeted treatment versus those who do not receive targeted treatment

Description

Time Frame

Up to 2 years

Other Pre-specified Outcome Measures:

Title

Genetic variant data

Description

Exploratory statistical genetic and bioinformatics analyses will be made 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

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela Alistar

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Cancer Center of Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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