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Phase I/II Trial of Radiation Therapy and Sorafenib for Treatment of Unresectable Liver Metastases

Phase 1/Phase 2
18 Years
Open (Enrolling)
Liver Metastasis, Cancer

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Trial Information

Phase I/II Trial of Radiation Therapy and Sorafenib for Treatment of Unresectable Liver Metastases

In this study, Stereotactic Body Radiation Therapy(SBRT) and Whole Liver Radiotherapy (WLRT)
will be used concurrently with sorafenib at 3 different dosages to determine the
tolerability and efficacy of this combined treatment. Sorafenib doses will be 200mg twice
daily orally for 28 days in level I, 400 mg in the morning and 200mg in the evening in level
II, and 400mg twice daily orally for 28 days in level III . Radiotherapy will be started at
day 8, patients will receive a total of 6 fractions over 2 weeks. Patients will be assessed
weekly during treatment, 1 month post-tx, then at 3-month intervals for up to a year after
tx, and then followed-up at 6-month intervals up to 3 years. Once the Maximum Tolerated
Dose (MTD) is established, an expanded cohort for each stratum will accrue such that a total
of 10 patients per strata. This will allow us to gain further experience with this regimen
and consolidate the safety and efficacy data. Quality of Life (QOL) assessment will be
carried out at baseline and 1/3/6/9 mos post-tx. Patients will also be offered correlative
studies looking at biomarkers through tissue, blood, and urine samples, and an imaging study
looking at tissue perfusion.

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

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD of sorafenib and RT in patients with liver metastases using an iso-toxicity radiation dose allocation scheme. Determine the acute toxicity (< 3 months) of sorafenib when combined with RT in patients with liver metastases.

Outcome Time Frame:

2 years enrollment; 3 years follow-up

Safety Issue:



Canada: Ethics Review Committee

Study ID:

UHN REB 08-0598-C



Start Date:

November 2008

Completion Date:

January 2015

Related Keywords:

  • Liver Metastasis
  • Cancer
  • Liver metastasis
  • sorafenib
  • Liver metastasis from cancer
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms