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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatocellular Carcinoma

Intervention: Gemcitabine (Drug); Oxaliplatin (Drug); Bevacizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Andrew Zhu, MD, Principal Investigator, Affiliation: Massachusetts General Hospital


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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.

Secondary outcome:

Number of participants with adverse events

Objective response rate

Overall survival

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Additional Information

Starting date: April 2004
Last updated: March 15, 2014

Page last updated: August 20, 2015

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