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

COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy

Sponsors

Lead Sponsor: Academic and Community Cancer Research United

Collaborator: National Cancer Institute (NCI)

Source Academic and Community Cancer Research United
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.

Overall Status Recruiting
Start Date April 22, 2020
Completion Date November 12, 2025
Primary Completion Date November 12, 2023
Study Type Observational
Primary Outcome
Measure Time Frame
Proportion of patients that enroll in the companion trial recommended by the Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy (COLOMATE) committee Up to 5 years
The proportion of patients who have an actionable genomic profile Up to 5 years
Enrollment 500
Condition
Intervention

Intervention Type: Other

Intervention Name: Genetic Testing

Description: Undergo genetic testing

Arm Group Label: Screening (genetic testing)

Eligibility

Sampling Method: Non-Probability Sample

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

- Willing to provide blood sample for screening purposes

- NOTE: Guardant360 testing completed =< 60 days prior to registration will be accepted.

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
John H Strickler Principal Investigator Academic and Community Cancer Research United
Location
Facility: Status: Contact: Investigator:
Mayo Clinic in Arizona | Scottsdale, Arizona, 85259, United States Recruiting Clinical Trials Referrals Office 855-776-0015 Tanios S. Bekaii-Saab Principal Investigator
UC San Diego Moores Cancer Center | La Jolla, California, 92093, United States Not yet recruiting ACCRU Operations 507-538-7459 [email protected] Shumei Kato Principal Investigator
USC / Norris Comprehensive Cancer Center | Los Angeles, California, 90033, United States Recruiting Carryl Du Bois 323-865-3084 [email protected] Heinz-Josef Lenz Principal Investigator
Cedars Sinai Medical Center | Los Angeles, California, 90048, United States Not yet recruiting Karen Kearns 253-831-3423 [email protected] Jun Gong Principal Investigator
MedStar Georgetown University Hospital | Washington, District of Columbia, 20007, United States Not yet recruiting ACCRU Operations 507-538-7453 [email protected] Benjamin A. Weinberg Principal Investigator
Emory University Hospital/Winship Cancer Institute | Atlanta, Georgia, 30322, United States Recruiting KJ Lee 404-778-3173 [email protected] Christina S. Wu Principal Investigator
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States Not yet recruiting ACCRU Operations 507-538-7458 [email protected] Daniel V. Catenacci Principal Investigator
Dana-Farber Cancer Institute | Boston, Massachusetts, 02215, United States Not yet recruiting ACCRU Operations 507-538-7450 [email protected] Kimmie Ng Principal Investigator
Mayo Clinic | Rochester, Minnesota, 55905, United States Recruiting Clinical Trials Referrals Office 855-776-0015 Joleen M. Hubbard Principal Investigator
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Not yet recruiting ACCRU Operations 507-538-7462 [email protected] Katrina S. Pedersen Principal Investigator
Memorial Sloan Kettering Cancer Center | New York, New York, 10065, United States Not yet recruiting ACCRU Operations 507-538-7457 [email protected] Andrea Cercek Principal Investigator
Duke University Medical Center | Durham, North Carolina, 27710, United States Recruiting Anthony Amara 919-668-1861 [email protected] John H. Strickler Principal Investigator
Allegheny General Hospital | Pittsburgh, Pennsylvania, 15212, United States Recruiting Karen Derzic 412-330-6263 [email protected] Gene G. Finley Principal Investigator
Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, 37232, United States Recruiting Kristen Ciombor 800-811-8480 Kristen K. Ciombor Principal Investigator
M D Anderson Cancer Center | Houston, Texas, 77030, United States Not yet recruiting ACCRU Operations 507-538-7456 [email protected] Benny Johnson Principal Investigator
Aurora Cancer Care-Milwaukee | Milwaukee, Wisconsin, 53209, United States Not yet recruiting ACCRU Operations 507-538-7449 [email protected] Federico Augusto H. Sanchez Principal Investigator
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Screening (genetic testing)

Description: Patients submit blood samples for genetic testing.

Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov