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Phase II Trial of Sorafenib in Combination With Modified FOLFOX in Patients With Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Cancer

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Trial Information

Phase II Trial of Sorafenib in Combination With Modified FOLFOX in Patients With Advanced Hepatocellular Carcinoma

After agreeing to participate in this study, the patient will be asked to undergo some
screening tests or procedures to find out if he/she is eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that the patient does not take part in the research study. If the patient has had some of
these tests or procedures recently, they may or may not have to be repeated. These tests and
procedures include: a medical history, physical exam, performance status, electrocardiogram,
assessment of tumor, blood tests, urine test, pregnancy test and optional research biopsy.
If these tests show that the patient is eligible to participate in the research study,
he/she will begin the study treatment. If the patient does not meet the eligibility
criteria, he/she will not be able to participate.

If the patient takes part in this research study, he/she will be given a sorafenib study
drug-dosing diary for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks),
during which time the patient will be taking the study drug twice daily. The diary will also
include special instructions for sorafenib.

There will be a 2-week Lead-in period, in which the patient will receive sorafenib alone for
the first two weeks of the study. Cycle 1 will begin once the patient receives the
combination sorafenib and FOLFOX.

For FOLFOX, all three chemotherapy drugs will be injected through a central vein in the
patient's chest (portacath) and will be given once every two weeks (14 days), starting on
Day 15 of Cycle 1. The patient will receive oxaliplatin first as a 2-hour infusion, followed
by leucovorin, and then 5-FU. The 5-FU infusion can last up to 46 hours and will be given
through a small portable pump. The investigator will ask the patient to come back to the
clinic on day 3 (46 hours after begin 5-FU dose) for pump discontinuance.

During all cycles the patient will have a physical exam and the patient will be asked
questions about his/her general health and specific questions about any problems that he/she
might be having and any medication he/she may be taking.

As part of the research study the patient will undergo research blood tests that will
measure certain proteins in the blood to learn what affect the study treatment may have on
you and your disease. About 1 teaspoon of blood will be drawn on Days 3 and 14 during your
first two weeks of sorafenib alone, again on Days 14 and 28 post-treatment with
FOLFOX-sorafenib and, if available, at the time of progression (if the patient's disease
gets worse).

The patient's blood pressure will be monitored once every week for the first 6 weeks of the
study (once a week during sorafenib lead-in period and Cycle 1). The investigator will asses
the patient's tumor by chest, abdominal and pelvic CT or MRI scan once every 8 weeks
throughout the study.

After the final dose of the study drug the investigator will ask the patient to come back to
the clinic to repeat the following procedures: medical review, physical examination, blood
tests, pregnancy test and tumor assessment by CT or MRI. The investigator would like to keep
track of patient's medical condition for the rest of his/her life. The investigator would
like to do this by calling the patient on the telephone once a year to see how the patient
is doing. Keeping in touch with the patient and checking his/her condition every year helps
the investigator look at the long-term effects of the research study.

Inclusion Criteria:

- Histologically confirmed advanced HCC

- Barcelona Clinic Liver Cancer stage C or stage B if you cannot tolerate or failed

- No cirrhosis or Child-Pugh A cirrhosis

- Measurable lesions

- All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 grade
1 or less

- Able to swallow and retain oral medication

Exclusion Criteria:

- Prior systemic regimens for HCC

- Uncontrolled hypertension

- CLIP score > 3

- ECOG PS > 1

- Clinically apparent central nervous system metastases or carcinomatous meningitis

- Pregnant or breastfeeding

- Active or clinically significant cardiac disease

- Evidence or history of bleeding diathesis or coagulopathy

- Any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4
weeks of enrollment

- Presence of a non-healing wound, non-healing ulcer, or bone fracture

- History of organ allograft

- Any malabsorption condition

- Medical or psychiatric condition that constitutes an unacceptable risk for
participation in this trial

- Have received another investigational agent within 4 weeks of first dose of sorafenib

- Previously untreated or concurrent cancer except those treated more than 3 years ago

- History of other disease, metabolic dysfunction, physical examination finding or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications

- QTC>500msec or history of uncontrolled angina, arrhythmias, or congestive heart

- Concurrent systemic and local anti-cancer therapy

- Prior use of sorafenib, oxaliplatin or 5FU

- Major surgery within 30 days

- Concurrent use of aspirin>100mg

- Therapeutic anticoagulation with vitamin K antagonists or with heparins or

Type of Study:


Study Design:

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

Outcome Measure:

Time to Progression

Outcome Description:

To assess the time to progression (TTP) in patients with HCC treated FOLFOX-S.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Andrew Zhu, MD, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2013

Completion Date:

February 2017

Related Keywords:

  • Hepatocellular Cancer
  • sorafenib
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617