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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 31, 2005

Last Updated Date

August 31, 2005

Start Date ^†

April 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current 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.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Hepatocellular Carcinoma

Intervention ^†

Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Bevacizumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00142467

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Massachusetts General Hospital

Collaborators ^††

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

Information Provided By

Massachusetts General Hospital

Verification Date

August 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.