We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00142467
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : March 18, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Gemcitabine Drug: Oxaliplatin Drug: Bevacizumab Phase 2

Detailed Description:
  • 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma
Study Start Date : April 2004
Primary Completion Date : August 2006
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bevacizumab, Gemcitabine, Oxaliplatin
For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.
Drug: Gemcitabine
Other Name: Gemzar
Drug: Oxaliplatin
Other Name: Eloxatin
Drug: Bevacizumab
Other Name: Avastin

Outcome Measures

Primary Outcome Measures :
  1. Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma. [ Time Frame: 2 years ]
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 2 years ]
  2. Objective response rate [ Time Frame: 2 years ]
  3. Overall survival [ Time Frame: 2 years ]
    From date of randomization until the date of death from any cause, assessed up to 2 years

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142467

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech, Inc.
Eli Lilly and Company
Principal Investigator: Andrew Zhu, MD Massachusetts General Hospital
More Information

Responsible Party: Andrew X. Zhu, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00142467     History of Changes
Other Study ID Numbers: 03-390
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Andrew X. Zhu, MD, Massachusetts General Hospital:
Unresectable hepatocellular carcinoma
Metastatic hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors