NCT00047333

Brief Summary

Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

3.4 years

First QC Date

October 3, 2002

Last Update Submit

January 22, 2013

Conditions

Adult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.

    Time from initiation of therapy until documented disease progression, assessed at 16 weeks

Secondary Outcomes (5)

  • Objective response rate

    Up to 4 years

  • Rate of stable disease

    Up to 4 years

  • Duration of stable disease

    From the start of the treatment until the criteria for progression are met, assessed up to 4 years

  • Time to progression

    Up to 4 years

  • Overall survival

    Up to 4 years

Study Arms (1)

Treatment (erlotinib hydrochloride)

EXPERIMENTAL

Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochlorideOther: laboratory biomarker analysisOther: pharmacological study

Interventions

erlotinib hydrochlorideDRUG

Given PO

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (erlotinib hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (erlotinib hydrochloride)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (erlotinib hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed hepatocellular carcinoma (HCC)not amenable to curative resection
  • No fibrolamellar HCC
  • No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents
  • The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study
  • Surgery
  • Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection)
  • At least 1 unidimensionally measurable lesion
  • At least 20 mm by conventional techniques
  • Must have paraffin tissue block or unstained slides from biopsy or surgical specimen
  • No known brain metastases
  • No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics)
  • Performance status - ECOG 0-2
  • At least 16 weeks
  • Granulocyte count at least 1,500/mm\^3
  • Platelet count at least 60,000/mm\^3
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Melanie Thomas

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

January 1, 2006

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)