Regorafenib in Metastatic Colorectal Cancer

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Bayer

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 Subjects permanently withdrawn from study participation will not be allowed to re-enter study.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.