Clinical trial NCT00142467: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Unresectable hepatocellular carcinoma
Metastatic hepatocellular carcinoma
gemcitabine
oxaliplatin
bevacizumab
Avastin
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Genentech, Inc.
name: Sanofi-Synthelabo
name: Eli Lilly and Company
First posted: 2005-09-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 2 years
measure: Objective response rate
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: