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

Stage III Rectal Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03765736
• Other study ID #: ACCRU-GI-1611
• Secondary ID: NCI-2018-02862AC
• Status: Terminated
• Start date: April 20, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Academic and Community Cancer Research United
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 199
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colonic Neoplasms
• Metastatic Colon Adenocarcinoma
• Metastatic Rectal Adenocarcinoma
• Rectal Neoplasms
• 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

Intervention

Other:
• Genetic Testing
Undergo genetic testing

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	M D Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Aurora Cancer Care-Milwaukee	Milwaukee	Wisconsin
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Academic and Community Cancer Research United	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	6 months
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).	3.5 years