TAS-102 With or Without Celecoxib in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
M.D. Anderson Cancer Center
Summary
To measure the level of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after 6 months of receiving TAS-102 therapy. ctDNA is genetic material from tumor cells that can be found and measured in the blood.
Description
Primary Objectives: The primary objective is to determine the 6-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy. Secondary Objectives: * To determine the 3-month ctDNA clearance rate in colorectal cancer patients with minimal residual disease. * To determine the disease free survival (DFS) amongst colorectal cancer patients with minimal residual disease following 6 months of TAS-102 therapy. * To determine the overall survival (OS) amongst colorectal cancer patients with minimal residual disease following 6 months…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Has histological confirmation of colorectal cancer 2. Received post-R0 resection of stages II, III, or IV colorectal cancer and has completed all planned curative intent therapies that must include ≥ 3 months of oxaliplatin containing chemotherapy 3. Has no definitive evidence of radiographic disease per assessment by investigators within 28 days (before or after) a positive ctDNA assay 4. Has minimal residual disease as defined by positive ctDNA assay (completed as standard-of-care at MD Anderson). Patients may be identified for enrollment with any Clinical Laboratory…
Interventions
- DrugTAS-102
GIven by PO
Location
- MD Anderson Cancer CenterHouston, Texas