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Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma

Phase 2
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma

- Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1
is only 2 weeks long.

- During cycle one only, bevacizumab will be given intravenously on day one. Two weeks
after receiving bevacizumab, the patient will return to the clinic for treatment with
all 3 study drugs.

- During cycle 2 and every cycle thereafter patients will receive; bevacizumab
intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16;
oxaliplatin intravenously on day 2 and day 16.

- The following evaluations will be conducted on day 1 and day 15 of each cycle (once
every 2 weeks): physical examination, vital signs, medical history, blood tests and
urine tests.

- Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and
every 2 cycles thereafter.

- Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and
Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment
during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.

- Once study treatment is stopped the following evaluations will be performed: physical
exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and
tumor measurements by CT or MRI scans.

- Follow-up will consist of physical examinations and blood tests every 6 months.

- Patients will continue to receive study treatment as long as there is no disease
progression or unacceptable side affects.

Inclusion Criteria:

- Unresectable or metastatic hepatocellular carcinoma

- Measurable tumors

- Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN

- Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000/mm3

- INR < 1.5 for those who are not on anticoagulation

- Up to two prior chemotherapy regimens for hepatocellular carcinoma

- 18 years of age or older

- ECOG performance status of 0-1

- Life expectancy of > 12 weeks

Exclusion Criteria:

- Clinically apparent central nervous system metastases or carcinomatous meningitis

- Uncontrolled serious medical or psychiatric illness

- Pregnant or lactating women

- Current or recent (within 4 weeks of first study infusion) participation in
experimental study drug

- Uncontrolled hypertension

- Significant proteinuria

- Serious, non-healing wound, ulcer, or bone fracture

- Evidence of bleeding diathesis or coagulopathy

Type of Study:


Study Design:

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

Outcome Measure:

To assess the time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.

Principal Investigator

Andrew Zhu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Unresectable hepatocellular carcinoma
  • Metastatic hepatocellular carcinoma
  • gemcitabine
  • oxaliplatin
  • bevacizumab
  • Avastin
  • Carcinoma
  • Carcinoma, Hepatocellular



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617