Status:
TERMINATED
Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Colon Adenocarcinoma
Metastatic Rectal Adenocarcinoma
Eligibility:
All Genders
18+ years
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...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT03765736
Start Date
April 20 2020
End Date
December 1 2023
Last Update
August 29 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
3
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048