Clinical trial NCT01987726: Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors
Official title: Decision Impact Analysis of Foundation Medicine's Next Generation Sequencing Test in Advanced Solid Tumor Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Breast Cancer
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Breast Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Keywords: Solid Tumor Malignancies
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Foundation Medicine
First posted: 2013-11-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with recurrent or metastatic a solid tumor cancer.

Brief summary: This pilot clinical trial studies comprehensive gene sequencing in guiding treatment recommendations in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the feasibility and logistics associated with a clinical trial utilizing the Foundation Medicine Incorporated (FMI) test in an academic therapeutic setting.

II. To determine the proportion of patients who will receive a cancer-related therapy based on the results provided by the FMI test.

SECONDARY OBJECTIVES:

I. To explore and report estimates of progression free survival (PFS) of the regimen administered after the FMI test results are revealed and the PFS of the most recent regimen administered before the FMI test results were received.

II. To determine the feasibility of performing Next Generation Sequencing (NGS) on metastatic tumor tissue.

III. To determine the feasibility of administering cancer-related drugs that are proposed by the results of NGS that are not Food and Drug Administration (FDA)-approved for a patient's specific cancer diagnosis.

IV. To collect and report the molecular alterations discovered by NGS of advanced breast and colorectal cancer.

V. To determine in an exploratory manner the concordance of the genomic alterations detected by the FMI test in circulating tumor cells (CTCs) to the genomic alterations detected by FMI test in tumor tissues collected from the same patient.

OUTLINE:

PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples and CTCs from patients are collected for NGS and FMI testing, respectively. Patients remain on current line of therapy until a change in treatment is warranted. The physician's treatment recommendation is documented prior to the release of the FMI results.

PART II: Physicians are furnished with FMI test results when patients become eligible for a change in therapy and new treatment recommendations are documented. Treatment is dependent on preferences of the physician, patient, and/or results of the FMI test.

After completion of study, patients are followed up for at least 18 months.

Eligibility criteria: Inclusion Criteria:

* Are able to understand and provide written informed consent (most recent patient informed consent form) prior to initiation of any study-specific procedures
* Patients are diagnosed with recurrent or metastatic a solid tumor cancer; the first patients to be enrolled will have a diagnosis of breast cancer (Cohort 1) or colorectal cancer (Cohort 2)
* Patients may enter this study at any line of therapy
* Patients must have a tumor sample available for NGS testing
* Patients are within 10 weeks of starting their current line of therapy and enrolled before their 1st computed tomography (CT) scan
* Have an expected survival of \>= 3 months, as estimated by the treating oncologist
* Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2

Exclusion Criteria:

* Are pregnant or nursing women
* Are unable to comply with requirements of the study
* Have a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection

Primary outcomes:
measure: Feasibility of NGS on metastatic solid tumor tissue, in terms of number of patients screened, FMI test attempted, FMI test successful, and FMI tests results released to physicians
timeFrame: Up to 18 months
measure: Feasibility of NGS result-based non-FDA-approved treatment plan, measured by reasons for ability or inability to receive an anti-cancer agent
timeFrame: Up to 18 months
measure: Availability of recommended experimental regimens via clinical trials
timeFrame: Up to 18 months
measure: Proportion of patients who have one recommended therapy
timeFrame: Up to 18 months
measure: Proportion of patients who have multiple options recommended
timeFrame: Up to 18 months
Secondary outcomes:
measure: Presence of any oncogene or tumor suppressor gene mutations or amplifications identified by NGS on tumor tissue in each cohort
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Maryam Lustberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adams EJ, Asad S, Reinbolt R, Collier KA, Abdel-Rasoul M, Gillespie S, Chen JL, Cherian MA, Noonan AM, Sardesai S, VanDeusen J, Wesolowski R, Williams N, Shapiro CL, Macrae ER, Pilarski R, Toland AE, Senter L, Ramaswamy B, Lee CN, Lustberg MB, Stover DG. Metastatic breast cancer patient perceptions of somatic tumor genomic testing. BMC Cancer. 2020 May 6;20(1):389. doi: 10.1186/s12885-020-06905-2.