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

This study has been terminated.
(Terminated due to funding issues.)
OSI Pharmaceuticals
Information provided by (Responsible Party):
Gabi Chiorean, MD, Hoosier Cancer Research Network Identifier:
First received: September 18, 2007
Last updated: January 14, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Erlotinib
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Erlotinib in Combination With Docetaxel in Advanced Hepatocellular and Biliary Tract Carcinomas: Hoosier Oncology Group GI06-101

Resource links provided by NLM:

Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • 16 Weeks Progression-free Survival [ Time Frame: Start of treatment until disease progression per RECIST criteria up to 16 weeks ]
    To determine the rate of progression-free survival (PFS) at 16 weeks for the combination therapy of erlotinib and docetaxel for subjects in the Biliary stratum, per RECIST criteria. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.

Secondary Outcome Measures:
  • Response Rate [ Time Frame: 18 months ]
    Determine the Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)

  • Overall Survival [ Time Frame: 18 Months ]
    Determine Overall Survival

Enrollment: 25
Study Start Date: September 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Drug: Erlotinib
Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28
Drug: Docetaxel
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

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

Detailed Description:

Outline: This is a multi-center study.

Patients who meet eligibility criteria will receive treatment as follows until disease progression or excessive toxicities:

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

Treatment cycle = 28 days

Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Life expectancy: At least 12 weeks


  • Absolute neutrophil count (ANC) > 1000 mm3
  • Platelet count > 75,000 mm3
  • Hemoglobin > 8 g/dL


  • Bilirubin < 2.0 x upper limit of normal (ULN)
  • Transaminases (AST, ALT) < 5.0 x ULN if alkaline phosphatase is < 2.5 x ULN, or alkaline phosphatase < 5 x ULN if transaminases are < 1.5 x ULN.
  • If not on anticoagulation: PT < 4 seconds above ULN; INR < 1.5; PTT < 1.3 x ULN.
  • If on therapeutic anticoagulation, patients may have an INR > 1.5 and PTT within therapeutic range; INR will be monitored weekly until stable.
  • Serum Albumin > 3.0


  • Creatinine clearance of > 60 ml/ min (by Cockcroft-Gault)


  • Not specified

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological proof of hepatocellular or biliary tract carcinomas, not amenable to curative resection or transplantation.
  • Prior cancer treatment completed at least 30 days prior to being registered for protocol therapy and recovered from the acute toxicity effects of the regimen.
  • Patients may have had radiofrequency ablation, cryosurgery or embolization, but must have documented progressive disease with the involved lesion, or at least one previously untreated lesion.
  • Patients may have had ≤ 2 prior chemotherapy regimens.
  • Prior radiation therapy allowed to < 25% of the bone marrow at least 30 days prior to being registered for protocol therapy.
  • Patients with biliary obstruction must have percutaneous transhepatic drainage or endoscopic stent placement prior to starting study treatment.
  • Patients with a history of malignancy are eligible provided they have been curatively treated and demonstrate no evidence for recurrence of that cancer.
  • Peripheral neuropathy ≤ grade 1.
  • Patients must agree to abstain from frozen or fresh grapefruit or grapefruit juice for 5 days prior to, and during treatment.
  • Patients must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for a 12 week period thereafter.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age ≥ 18 years at time of consent.

Exclusion Criteria:

  • No previous treatment with EGFR inhibitors.
  • No treatment with any investigational agent within 30 days prior to being registered for protocol therapy.
  • No symptomatic brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis, no longer require corticosteroids, and are asymptomatic.
  • No Child-Pugh B or C liver cirrhosis.
  • No active corneal erosions or history of abnormal corneal sensitivity test.
  • No history of aneurysm or arteriovenous malformation.
  • No hemorrhage/bleeding event > CTCAE Grade 3 within 30 days prior to begin registered for protocol therapy.
  • No clinically significant infections as judged by the treating investigator.
  • No condition that impairs patient's ability to swallow whole pills.
  • No history of hypersensitivity to docetaxel or other drugs formulated with polysorbate 80.
  • Females must not be breastfeeding.
  • Patients who cannot avoid the following medications will be ineligible for the trial: midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, phenobarbital, phenytoin, carbamazepine, and rifampin (induction) and anti-retrovirals (including ritonavir, saquinavir).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00532441

United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Rush-Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, United States, 46815
IN Onc/Hem Associates
Indianapolis, Indiana, United States, 46202
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Quality Cancer Center (MCGOP)
Indianapolis, Indiana, United States, 46202
Medical Consultants, P.C.
Muncie, Indiana, United States, 47303
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
Sponsors and Collaborators
Gabi Chiorean, MD
OSI Pharmaceuticals
Study Chair: Elena Gabriela Chiorean, M.D. Hoosier Oncology Group, LLC
  More Information

Additional Information:
Responsible Party: Gabi Chiorean, MD, Principal Investigator, Hoosier Cancer Research Network Identifier: NCT00532441     History of Changes
Other Study ID Numbers: GI06-101
Study First Received: September 18, 2007
Results First Received: December 10, 2015
Last Updated: January 14, 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on May 25, 2017