Sorafenib-RT Treatment for Liver Metastasis (SLIM)

• Status: Completed
• Trial end date: 2020-09-08
• Target enrollment: 0
• Participant gender: All

Summary

Cancers that have spread to the liver from the primary cancer location (liver metastases) that cannot be removed surgically (unresectable) can be treated with chemotherapy and/or radiation therapy. Previous research has shown that tumours often have abnormal blood vessels that may reduce the effect of radiation therapy. New drugs, known as "anti-angiogenic" drugs have been shown in animal and human studies to damage or change tumour blood vessels in ways that may make tumors more sensitive to radiation treatment. 32- 44 Patients diagnosed with unresectable liver metastasis will be invited to take part in this study. The purpose of this study is to investigate the use of a new anti-angiogenic drug called Sorafenib, in combination radiation therapy and chemotherapy. The study will test how effective the new treatment is, the side effects associated with the new treatment, and to help establish safe dosages of the study medication.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Histologically confirmed liver metastases

• Largest burden of disease should be hepatic if there's extrahepatic disease exists

• Tumour should be medically inoperable

• Patient have a life expectancy of at least 3 months and a KPS performance status of at least 60%.

• Patient should be 18 years of age or older

• Patient should have adequate organ function

• Patient have Creatinine ≤ 2 times upper limit of normal range

• Patient recovered from the effects of prior therapy

• Patient (or person representing the patient) should be able to give informed consent

• Patient have Child's A score (5 or 6) score

• For women of childbearing age, birth control is being used and the pregnancy test is negative

Exclusion Criteria:

• No major surgery in the past 4 weeks.

• No previous use of sorafenib previously.

• Patient should not have or is receiving systemic therapy or investigational agents within 2 weeks of radiotherapy

• No previous upper abdominal radiation therapy to the liver.

• No serious medical conditions that may be aggravated by treatment, including but not limited to: myocardial infarction within 6 months, congestive cardiac failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders,serious infections, active peptic ulcer disease, active liver disease or previous stroke.

• Patients who are infected with human immunodeficiency virus (HIV), should not be receiving combination anti-retroviral therapy

• No clinically significant liver failure (i.e. encephalopathy or ascites found clinically).

• No thrombolytic therapy within 4 weeks or are they receiving other anticoagulant therapy.

• No underlying cirrhosis with Child's B or C score.

• No history of uncontrolled, life threatening malignancy within the past 6 months.

• Patient should not have a variceal bleed or other gastrointestinal bleed in the past 2 months.

• No brain metastases

• Patient should not be pregnant.

• Patients on Rifampin, St. John's Wort, Phenytoin, Carbamazepine, Phenobarbital, or Chronic use (more than 4 weeks) of dexamethasone