Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas

Part of paid clinical trials in Newark, Delaware.

Sponsor
Gabi Chiorean, MD
Study ID
NCT00532441
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
  • Docetaxel — DRUG
    Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Study Details

An unmet medical need exists for the successful therapy of patients with advanced hepatocellular and biliary tract malignances, with few and short lived disease responses to chemotherapy for both advanced stage hepatic and biliary carcinomas. Pre-clinical data shows cooperative antitumor activity between an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor and taxanes. The efficacy of erlotinib in combination with docetaxel will be assessed in this trial.

Key Dates

First listed
Sep 20, 2007
Start date
Sep 30, 2007
Status verified
Jan 2016
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib and Docetaxel: Biliary
    Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
  • Experimental: Erlotinib and Docetaxel: Hepatocellular
    Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15

Primary Outcome Measure

16 Weeks Progression-free Survival [ Time Frame: Start of treatment until disease progression per RECIST criteria up to 16 weeks ]

Locations (12)

FacilityCityStateZIPSite coordinators
Helen F. Graham Cancer CenterNewarkDelaware19713-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Rush-Presbyterian St. Luke's Medical CenterChicagoIllinois60612-
Cancer Care Center of Southern IndianaBloomingtonIndiana47403-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
IN Onc/Hem AssociatesIndianapolisIndiana46202-
Indiana University Cancer CenterIndianapolisIndiana46202-
Quality Cancer Center (MCGOP)IndianapolisIndiana46202-
Medical Consultants, P.C.MuncieIndiana47303-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
Siteman Cancer CenterSt LouisMissouri63110-
Methodist Cancer CenterOmahaNebraska68114-

Find similar trials in Newark, DE

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Helen F. Graham Cancer Center· Newark, DENorthwestern University Feinberg School of Medicine· Chicago, ILRush-Presbyterian St. Luke's Medical Center· Chicago, ILCancer Care Center of Southern Indiana· Bloomington, INFort Wayne Oncology & Hematology, Inc· Fort Wayne, ININ Onc/Hem Associates· Indianapolis, IN

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