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