Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Brigham and Women's Hospital Genentech Sanofi-Synthelabo Eli Lilly and Company
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00142467

Purpose

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	Intervention	Phase
Hepatocellular Carcinoma	Drug: Gemcitabine Drug: Oxaliplatin Drug: Bevacizumab	Phase II

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Bevacizumab Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	April 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142467

Locations

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

Sanofi-Synthelabo

Eli Lilly and Company

Investigators

Principal Investigator:

Andrew Zhu, MD

Massachusetts General Hospital

More Information

Study ID Numbers:	03-390
Study First Received:	August 31, 2005
Last Updated:	August 31, 2005
ClinicalTrials.gov Identifier:	NCT00142467
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Unresectable hepatocellular carcinoma
Metastatic hepatocellular carcinoma
gemcitabine

oxaliplatin
bevacizumab
Avastin

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Bevacizumab
Carcinoma
Liver Neoplasms

Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Gemcitabine
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Angiogenesis Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009