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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142467
First Posted: September 2, 2005
Last Update Posted: March 18, 2014
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.
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech, Inc.
Sanofi-Synthelabo
Eli Lilly and Company
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital
August 31, 2005
September 2, 2005
March 18, 2014
April 2004
August 2006   (Final data collection date for primary outcome measure)
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
To assess the time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
Complete list of historical versions of study NCT00142467 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: 2 years ]
  • Objective response rate [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]
    From date of randomization until the date of death from any cause, assessed up to 2 years
To evaluate the side effects of this drug combination in this population of patients as well as the response rate, duration of response and median survival.
Not Provided
Not Provided
 
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma
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.
  • 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: Gemcitabine
    Other Name: Gemzar
  • Drug: Oxaliplatin
    Other Name: Eloxatin
  • Drug: Bevacizumab
    Other Name: Avastin
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.
Interventions:
  • Drug: Gemcitabine
  • Drug: Oxaliplatin
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2011
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00142467
03-390
Yes
Not Provided
Not Provided
Andrew X. Zhu, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Genentech, Inc.
  • Sanofi-Synthelabo
  • Eli Lilly and Company
Principal Investigator: Andrew Zhu, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP