Regorafenib in Metastatic Colorectal Cancer

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-002864
    NCT ID: NCT02466009
    Sponsor Protocol Number: UGIC-14072

About this study

The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma
  • Measurable metastatic disease.
  • Age +/> 70
  • Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
  • Life expectancy ≥ 12 weeks
  • Able to understand and willing to sign written informed consent.
  • Laboratory requirements:
  • Total bili ≤ 1.5 x upper limit or normal
  • Alanine aminotransferase & Asparate aminotransferase ≤ 2.5 x upper limit or normal
  • Serum creatinine ≤ 1.5 x upper limit or normal
  • International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
  • Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria not be allowed.
  • Glomerular filtration rate ≥ 60 ml/min
  • Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug.
  • Must be able to swallow and retain oral medications

Exclusion Criteria:

  • Currently receiving other systemic therapy for metastatic colorectal cancer
  • Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
  • Uncontrolled hypertension despite optimal medical management
  • Active or clinically significant cardiac disease.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent
  • History of other active malignancy within past 2 years.
  • Patients with phaeochromocytoma
  • Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection.
  • Ongoing infection > grade 2
  • Symptomatic metastatic brain or meningeal tumors
  • Presence of non-healing wound, non-healing ulcer, or bone fracture
  • Renal failure requiring hemo- or peritoneal dialysis
  • Dehydration ≥ grade 1
  • Patients with seizure disorder requiring medication
  • Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
  • Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea
  • History of organ allograft including corneal transplant
  • Known or suspected allergy or hypersensitivity to the study drug
  • Any malabsorption condition
  • Any condition which makes the subject unsuitable for trial participation
  • Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joleen Hubbard, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

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

International patient clinical studies questions