NCT00142428

Brief Summary

The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic hepatocellular carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jan 2005

Typical duration 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

January 1, 2005

Completed
8 months 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
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

August 31, 2005

Last Update Submit

March 16, 2014

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomacetuximabUnresectable hepatocellular carcinomaMetastatic hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival in patients treated with cetuximab for unresectable or metastatic hepatocellular carcinoma

    2 years

Secondary Outcomes (3)

  • Number of patients with adverse events

    2 years

  • Overall Survival

    2 years

  • Objective Response Rate

    2 years

Study Arms (1)

Cetuximab

EXPERIMENTAL

The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks.

Drug: Cetuximab

Interventions

CetuximabDRUG

The initial dose of cetuximab was 400 mg/m2 (cycle 1 only) given intravenously followed by weekly intravenous infusions at 250 mg/m2. Each cycle was defined as 6 consecutive weekly intravenous treatments. Treatment was continued until 1 of the following criteria was met: disease progression per RECIST criteria, unacceptable toxicity, patient refusal, or the need to delay therapy more than 3 weeks.

Cetuximab

Eligibility Criteria

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

You may qualify if:

  • Unresectable or metastatic hepatocellular carcinoma
  • Measurable tumor
  • Adequate hepatic function: total bilirubin \< 3.0mg/dl; AST \< 7 x upper limit of normal (ULN).
  • Adequate renal function: serum creatinine \< 2.0mg/dl
  • Adequate bone marrow function: absolute neutrophil count (ANC) \> 1,000/mm3; platelets \> 75,000/mm3.
  • prior systemic chemotherapy regimens for hepatocellular carcinoma
  • years of age and older
  • ECOG performance status of 0-2
  • Life expectancy \> 12 weeks

You may not qualify if:

  • Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry
  • Uncontrolled serious medical or psychiatric illness
  • Irradiation or chemotherapy for disease within 28 days of study entry
  • Clinically apparent central nervous system metastases or carcinomatous meningitis
  • Received an investigational agent within 30 days
  • Cancer of the Liver Italian Program (CLIP) score \> 3
  • Acute hepatitis
  • Active or uncontrolled infection
  • Significant history of cardiac disease
  • Prior cetuximab or other therapy which specifically and directly targets the EGFR pathway
  • Prior allergic reaction to chimerized or murine monoclonal antibody therapy

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

Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Andrew X. 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

January 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2008

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(3)