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NCT03765736 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

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
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