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

• Sponsor: Academic and Community Cancer Research United (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03765736
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 500
• Locations: 18
• Anticipated Duration (Months): 66.8
• Patients Per Site: 27.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colon Adenocarcinoma; Metastatic Rectal Adenocarcinoma; Stage III Colon Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; 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 IIIC Rectal Cancer AJCC v8; Stage IV Colon Cancer AJCC v8; Stage IV 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 IVC Rectal Cancer AJCC v8; Unresectable Colon Adenocarcinoma; Unresectable Rectal Adenocarcinoma	Other: Genetic Testing

Detailed Description

PRIMARY OBJECTIVES:

1. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.

2. To facilitate clinically annotated genomic analyses.

OUTLINE:

Patients submit blood samples for genetic testing.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy
• Actual Study Start Date: Apr 20, 2020
• Anticipated Primary Completion Date: Nov 12, 2023
• Anticipated Study Completion Date: Nov 12, 2025

Arms and Interventions

Arm	Intervention/Treatment
Screening (genetic testing) Patients submit blood samples for genetic testing.	Other: Genetic Testing; Undergo genetic testing; Other Names: genetic analysis Genetic Examination Genetic Test

Outcome Measures

Primary Outcome Measures

1. The proportion of patients who have an actionable genomic profile [Up to 5 years]

   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).

2. Companion trial enrollment [Up to 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	MedStar Georgetown University Hospital	Washington	District of Columbia	United States	20007
6	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980
7	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia	United States	30322
8	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
9	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
10	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
11	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
12	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
13	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
14	Duke University Medical Center	Durham	North Carolina	United States	27710
15	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
16	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee	United States	37232
17	M D Anderson Cancer Center	Houston	Texas	United States	77030
18	Aurora Cancer Care-Milwaukee	Milwaukee	Wisconsin	United States	53209

Sponsors and Collaborators

• Academic and Community Cancer Research United
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: John H Strickler, Academic and Community Cancer Research United

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Academic and Community Cancer Research United
• ClinicalTrials.gov Identifier: NCT03765736
• Other Study ID Numbers: ACCRU-GI-1611; NCI-2018-02862; ACCRU-GI-1611; P30CA015083
• First Posted: Dec 5, 2018
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Adenocarcinoma; Rectal Neoplasms; Colonic Neoplasms

Study Results

No Results Posted as of May 11, 2022