Regorafenib in Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Regorafenib
Intervention description: Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Colorectal cancer; metastatic colorectal cancer; colorectal adenocarcinoma

Summary:

      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.
    

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 Subjects permanently withdrawn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.