Colon Cancer Clinical Trial

Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

199

Study ID:

NCT03765736

Recruitment Status:

Terminated

Sponsor:

Academic and Community Cancer Research United

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There are 18 Locations for this study

See Locations Near You

Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
Aurora Cancer Care-Milwaukee
Milwaukee Wisconsin, 53209, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

199

Study ID:

NCT03765736

Recruitment Status:

Terminated

Sponsor:


Academic and Community Cancer Research United

How clear is this clinincal trial information?

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