A Study to Evaluate Trifluridine/Tipiracil Combined with Bevacizumab vs Trifluridine/Tipiracil to Treat Patients with Refractory Metastatic Colorectal Cancer

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory metastatic colorectal cancer (mCRC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded).
  • RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy.
  • Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.
  • Has measurable or non-measurable disease as defined by RECIST version 1.1.
  • Is able to swallow oral tablets.
  • Estimated life expectancy ≥ 12 weeks.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.

Exclusion Criteria:

  • More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer.
  • Pregnancy, lactating female or possibility of becoming pregnant during the study.
  • Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization.
  • Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation).
  • Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
  • Has severe or uncontrolled active acute or chronic infection.
  • Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
  • Known Hepatitis B or Hepatitis C Virus infection.
  • Known carriers of HIV antibodies.
  • Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia.
  • Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization.
  • Treatment with any of the following within the specified time frame prior to randomization:
    • major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study;
    • prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only;
    • drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization.
  • Other clinically significant medical conditions.
  • Other malignancies.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Zhaohui Jin, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Jeremy Jones, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions