Study Details

Open

Comparison of Two Anticancer Drug Combinations in Colorectal Cancer

The purpose of this study is to compare the effects of two anticancer drugs when each is given in combination with standard colorectal cancer chemotherapy to participants with metastatic colorectal cancer that lack mutations in genes called KRAS/NRAS and BRAF.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will come to clinic to complete screening procedures to see if you are eligible for the study. These procedures include imaging, tissue collection, and labs. If you are eligible, you will receive the standard chemotherapy and one of the study drugs. The treatment period includes receiving the study treatment, labs, exam, imaging, questionnaires, and biopsy of your tumor. After you complete treatment, you will return to clinic for physical exam, labs, and imaging. You will be them followed by the study team.

Incentives

Reimbursement related to attending study visits

In-person visits:
1-2 visits for screening, 4 visits per cycle, and End of Treatment visit

Phone or online visits:
Questionnaires may be done online or by phone in follow up

Total length of participation:
1 month screening, 1 month each treatment cycle until off treatment, follow-up every 12 weeks until end of study, withdrawal of consent, or death

Looking for Specific Volunteers

Able to participate:

A diagnosis of confirmed adenocarcinoma of the left-sided colorectal cancer that is either unresectable or metastatic disease.
Diagnosed with a KRAS, NRAS, or BRAF WT tumor.
Must agree to tumor tissue biopsies
Has not received any prior therapy for unresectable or metastatic colorectal cancer.
Has adequate renal, hepatic, and hematologic function per protocol required labs.

Not eligible if:

Has an uncontrolled illness such as diabetes mellitus, ongoing or active infections, history of bleeding events, gastrointestinal perforation, etc.
Has a history of clinically significant heart disease per protocol.
Has a known presence of leptomeningeal disease or spinal cord compression.
Has active hepatitis of infectious origin per protocol.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Hanna Sanoff
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Colorectal)

IRB Number

24-2429

ClinicalTrials.gov

NCT06662786