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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142467
• Other study ID #: 03-390
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: March 15, 2014
• Start date: April 2004
• Est. completion date: June 2011

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2011
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Gemcitabine

• Oxaliplatin

• Bevacizumab

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (7)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Eli Lilly and Company, Genentech, Inc., Sanofi-Synthelabo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.	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	2 years	No
Secondary	Number of participants with adverse events		2 years	Yes
Secondary	Objective response rate		2 years	No
Secondary	Overall survival	From date of randomization until the date of death from any cause, assessed up to 2 years	2 years	No