Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage IIIA Colon Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Colon Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IVA Colon Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IVC Rectal Cancer AJCC v8, Stage IV Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Rectal Adenocarcinoma
Conditions
Brief summary
This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.
Detailed description
PRIMARY OBJECTIVES: I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies. II. To facilitate clinically annotated genomic analyses. OUTLINE: Patients submit blood samples for genetic testing.
Interventions
OTHERGenetic Testing
Undergo genetic testing
Sponsors
National Cancer Institute (NCI)
Academic and Community Cancer Research United
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable * Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H) * For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab) * Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required * At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation * Life expectancy \>= 3 months per estimation of investigator * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Capable of understanding and complying with the protocol requirements and has signed the informed consent document * Satisfy at least one of the following two conditions: * Willing and able to provide blood sample for screening purposes * Guardant 360 testing completed =\< 60 days prior to registration
Exclusion criteria
* Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of \< 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration * Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee * History of solid organ transplantation * Pregnant or planning to become pregnant within the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients Who Have an Actionable Genomic Profile | 6 months | This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit). |
| Companion Trial Enrollment | 3.5 years | This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Screening (Genetic Testing) Patients submit blood samples for genetic testing.
Genetic Testing: Undergo genetic testing | 197 |
| Total | 197 |
Baseline characteristics
| Characteristic | Screening (Genetic Testing) |
|---|---|
| Age, Continuous | 57.4 years STANDARD_DEVIATION 11.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 174 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Primary Tumor Site Left | 146 Participants |
| Primary Tumor Site Multiple/Other | 11 Participants |
| Primary Tumor Site Right | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 132 Participants |
| Region of Enrollment United States | 197 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Companion Trial Enrollment
This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
Time frame: 3.5 years
Population: All eligible patients who had an actionable genomic profile were included in analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screening (Genetic Testing) | Companion Trial Enrollment | 26.76 percent of participants |
Primary
The Proportion of Patients Who Have an Actionable Genomic Profile
This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
Time frame: 6 months
Population: All eligible patients whose genomic profile was available for COLOMATE steering committee review are included in analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Screening (Genetic Testing) | The Proportion of Patients Who Have an Actionable Genomic Profile | 37.17 percent of participants |