Study on TAS-102 With or Without Celecoxib for Detecting Minimal Residual Disease in Colorectal Cancer After Chemotherapy

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05343013

Provider View

This clinical trial is examining whether the drug TAS-102, with or without Celecoxib, can help detect minimal residual disease in colorectal cancer patients by measuring circulating tumor DNA (ctDNA) in the blood after chemotherapy.

Patient Parameters

Program Overview

The study aims to measure the levels of circulating tumor DNA (ctDNA) in the blood of colorectal cancer patients after they have completed 6 months of treatment with TAS-102. ctDNA is genetic material from tumor cells that can be found in the blood and may indicate the presence of minimal residual disease.

Description

The main goal of this study is to find out how many colorectal cancer patients have no detectable ctDNA in their blood after 6 months of treatment with TAS-102. Researchers will also look at ctDNA levels after 3 months, as well as how long patients remain free of cancer and their overall survival rates. The study will assess the safety and side effects of TAS-102 in these patients.

Additionally, the study will explore various markers in tumor tissue and blood that might predict how well patients respond to treatment or if they might resist it. This includes looking at immune cells in the tumor and changes in ctDNA and lymphocytes during treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with colorectal cancer.
  • Completed surgery and at least 3 months of chemotherapy for stages II, III, or IV colorectal cancer.
  • No visible signs of cancer on scans within 28 days of a positive ctDNA test.
  • Positive ctDNA test indicating minimal residual disease, confirmed by a specific test if needed.
  • Good organ and bone marrow function, with specific blood test results:
    • Neutrophil count: ≥1,000/mcL
    • Platelets: ≥100,000/mcL
    • Total bilirubin: ≤ normal limits
    • Liver enzymes: ≤3 times normal limits
    • Kidney function: Serum creatinine ≤ 1.5 times normal or creatinine clearance ≥60 mL/min
  • ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Aged 18 years or older.
  • Able to understand and willing to sign informed consent.
  • Willing to use effective contraception during the study and for 7 months after the last dose.

Exclusion Criteria

  • Have other active cancers that could interfere with ctDNA analysis.
  • Have significant electrolyte imbalances that are clinically concerning.
  • Have severe health conditions, such as autoimmune or heart disorders, that could affect participation.
  • Have ongoing side effects from previous treatments, except for hair loss or nerve damage, that are moderate or severe.
  • Have any condition that could interfere with the study or pose a risk, as judged by the investigators.
  • Have allergies to the study drugs or their ingredients.
  • Are pregnant or breastfeeding.
  • Cannot take oral medication or have conditions affecting drug absorption.
  • Are taking other investigational drugs.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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