Erlotinib Hydrochloride in Preventing Liver Cancer in Patients With Cirrhosis of the Liver

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02273362
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    Given PO
  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This pilot phase I/II trial studies the best dose of erlotinib hydrochloride and to see how well it works in preventing liver cancer in patients with scarring (cirrhosis) of the liver. Erlotinib hydrochloride may help to inhibit the development of fibrous tissue and prevent liver cancer from forming in patients with cirrhosis of the liver.

Key Dates

First listed
Oct 24, 2014
Start date
Nov 24, 2014
Status verified
Feb 2024
Primary completion
Feb 11, 2020
Completion
Mar 10, 2022

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Prevention (erlotinib hydrochloride)
    Patients receive erlotinib hydrochloride PO QD for 7 days (depending on the date of surgery, treatment range may be 5-14 days).

Primary Outcome Measure

Response (at Least a 50% Reduction in Liver Phospho-EGFR Staining) [ Time Frame: Up to day 7 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Mayo Clinic in RochesterRochesterMinnesota55905-
Mount Sinai HospitalNew YorkNew York10029-
Case Western Reserve UniversityClevelandOhio44106-
Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Jacksonville, FL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Mayo Clinic in Florida· Jacksonville, FLMassachusetts General Hospital Cancer Center· Boston, MAMayo Clinic in Rochester· Rochester, MNMount Sinai Hospital· New York, NYCase Western Reserve University· Cleveland, OHCleveland Clinic Foundation· Cleveland, OH

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