NCT00142467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

August 31, 2005

Last Update Submit

March 15, 2014

Conditions

Hepatocellular Carcinoma

Keywords

Unresectable hepatocellular carcinomaMetastatic hepatocellular carcinomagemcitabineoxaliplatinbevacizumabAvastin

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Number of participants with adverse events

    2 years

  • Objective response rate

    2 years

  • Overall survival

    2 years

Study Arms (1)

Bevacizumab, Gemcitabine, Oxaliplatin

EXPERIMENTAL

For cycle 1 (14 days), bevacizumab 10 mg/kg was administered alone on day 1. For cycle 2 and beyond (28 days/cycle), bevacizumab 10 mg/kg was administered on days 1 and 15, gemcitabine 1,000 mg/m2 was administered as a dose rate infusion at 10 mg/m2/min followed by oxaliplatin at 85 mg/m2 on days 2 and 16. All drugs were administered intravenously until progression, intolerance, patient withdrawal, or death.

Drug: GemcitabineDrug: OxaliplatinDrug: Bevacizumab

Interventions

GemcitabineDRUG
Also known as: Gemzar
Bevacizumab, Gemcitabine, Oxaliplatin
OxaliplatinDRUG
Also known as: Eloxatin
Bevacizumab, Gemcitabine, Oxaliplatin
BevacizumabDRUG
Also known as: Avastin
Bevacizumab, Gemcitabine, Oxaliplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older
  • ECOG performance status of 0-1
  • Life expectancy of \> 12 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

GemcitabineOxaliplatinBevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andrew Zhu, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2006

Study Completion

June 1, 2011

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(3)