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Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033462
  Purpose

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer.


Condition Intervention Phase
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: Cancer Gallbladder Cancer Liver Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of OSI-774 In Patients With Hepatocellular Or Biliary Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
Detailed Description:

OBJECTIVES:

  • Determine the progression-free rate at 24 weeks in patients with unresectable hepatocellular or biliary carcinoma treated with erlotinib.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the objective response rate in patients treated with this drug.
  • Determine the overall and progression-free survival of patients treated with this drug.
  • Correlate epidermal growth factor receptor protein levels with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary).

Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 3 years.

PROJECTED ACCRUAL: A total of 78 patients (39 per group) will be accrued for this study within 13 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed hepatocellular or biliary carcinoma

    • Unresectable disease
    • Noninvasive diagnosis of unresectable hepatocellular carcinoma by hypervascular mass on CT scan and alpha fetoprotein greater than 100 ng/mL allowed
  • Measurable disease

    • At least 1 lesion with diameter at least 2.0 cm
    • Indicator lesions must be outside of prior treatment area and edges of lesions must be clearly distinct

      • Patients whose sole indicator lesion is inside prior treatment area are eligible provided the lesion shows clear evidence of disease progression
  • Child-Pugh classification A or B
  • No ampulla of Vater tumors
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN
  • INR no greater than 1.5 (for patients not receiving anticoagulation)
  • Albumin at least 2.5 g/dL

Renal:

  • Creatinine no greater than 2 mg/dL

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Gastrointestinal:

  • No requirement for IV alimentation
  • No gastrointestinal tract disease resulting in an inability to take oral medication
  • No active peptic ulcer disease

Ophthalmic:

  • No known abnormalities of the cornea including, but not limited to, the following:

    • Dry eye syndrome or Sjögren's syndrome
    • Congenital abnormality (e.g., Fuch's dystrophy)
    • Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
    • Abnormal corneal sensitivity test (Schirmer test or similar tear production test)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant traumatic injury within the past 3 weeks
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma of the cervix
  • No ongoing or active infection
  • No concurrent uncontrolled medical or psychiatric illness or social situation that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 4 weeks since prior immunotherapy or biologic therapy
  • No concurrent immunotherapy

Chemotherapy:

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No more than 1 prior systemic anticancer therapy

    • Chemoembolization considered 1 prior chemotherapeutic regimen
  • No concurrent chemotherapy

Endocrine therapy:

  • No concurrent anti-cancer hormonal agents

Radiotherapy:

  • More than 4 weeks since prior radiotherapy
  • No concurrent radiotherapy (including whole brain irradiation for documented CNS metastasis)

Surgery:

  • More than 3 weeks since prior major surgery
  • More than 6 weeks since prior cryotherapy

Other:

  • Recovered from prior therapy
  • More than 6 weeks since prior radiofrequency ablation, ethanol injection, or photodynamic therapy
  • No prior epidermal growth factor receptor-targeting therapy
  • No prior procedures affecting absorption
  • No concurrent combination anti-retroviral therapy for HIV-positive patients
  • No other concurrent investigational therapy or supportive care
  • No other concurrent anticancer medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033462

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, District of Columbia
Howard University Hospital
Washington, District of Columbia, United States, 20060-0001
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000069285, MAYO-MC0152, NCI-5429
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033462  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized unresectable adult primary liver cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
unresectable gallbladder cancer
recurrent gallbladder cancer
unresectable extrahepatic bile duct cancer
recurrent extrahepatic bile duct cancer
adult primary hepatocellular carcinoma
cholangiocarcinoma of the gallbladder
cholangiocarcinoma of the extrahepatic bile duct
adult primary cholangiocellular carcinoma

Study placed in the following topic categories:
Erlotinib
Bile duct cancer, extrahepatic
Gallbladder Diseases
Cholangiocarcinoma
Liver Diseases
Biliary Tract Neoplasms
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Recurrence
Gall bladder cancer
Carcinoma
Liver Neoplasms
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Gastrointestinal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009