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Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00047333
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed.


Condition Intervention Phase
Liver Cancer
Drug: erlotinib hydrochloride
Phase II

MedlinePlus related topics: 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 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma

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

Primary Outcome Measures:
  • Progression-free survival as measured by NCI RECIST criteria at 16 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate as measured by NCI RECIST criteria every 8 weeks [ Designated as safety issue: No ]
  • Rate and duration of stable disease as measured by NCI RECIST criteria every 8 weeks [ Designated as safety issue: No ]
  • Time to progression as measured by NCI RECIST criteria every 8 weeks [ Designated as safety issue: No ]
  • Overall survival from registration till death [ Designated as safety issue: No ]
  • Safety as measured by NCI RECIST criteria v3.0 continously [ Designated as safety issue: Yes ]
  • Pharmacokinetic and pharmacodynamic profile by a compartmental and noncompartmental model during 1st course [ Designated as safety issue: No ]
  • Correlated response with patient characteristics at end of study [ Designated as safety issue: No ]

Study Start Date: August 2002
Detailed Description:

OBJECTIVES:

  • Determine the 16-week progression-free survival of patients with unresectable hepatocellular carcinoma treated with erlotinib.
  • Determine the objective response rate, rate and duration of stable disease, and time to progression in patients treated with this drug.
  • Determine the median and overall survival of patients treated with this drug.
  • Determine the pharmacokinetic and pharmacodynamic profiles of this drug in these patients.
  • Determine the safety and tolerability of this drug in these patients.
  • Correlate response to this drug with patient characteristics (e.g., age, disease stage, viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, performance status, serum values of alpha-fetoprotein, bilirubin, transaminases, and albumin, epidermal growth factor receptor expression, and development of skin rash during therapy).

OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+).

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

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study within 25-50 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 16 weeks

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 60,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 1.8 mg/dL
  • Albumin at least 2.5 g/dL
  • AST/ALT no greater than 5 times upper limit of normal
  • PT no greater than 1-3 seconds over normal
  • No decompensated liver disease
  • No jaundice
  • No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius)
  • No hyponatremia with sodium less than 125 mEq/L
  • No portal hypertension with bleeding esophageal or gastric varices within the past 3 months

Renal

  • Creatinine no greater than 2 mg/dL

Cardiovascular

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

Gastrointestinal

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

Ophthalmic

  • No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
  • No congenital abnormality (e.g., Fuch's dystrophy)

Other

  • No other uncontrolled concurrent illness that would preclude study participation
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  • No prior surgical therapy affecting absorption

Other

  • More than 30 days since prior investigational agents
  • No concurrent commercial or other investigational anticancer agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047333

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Melanie B. Thomas, MD M.D. Anderson Cancer Center
  More Information

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

Study ID Numbers: CDR0000257665, MDA-ID-02008, NCI-5953
Study First Received: October 3, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00047333  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer

Study placed in the following topic categories:
Erlotinib
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

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

ClinicalTrials.gov processed this record on January 15, 2009