search
Back to results

Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

Primary Purpose

Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
laboratory biomarker analysis
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Primary Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Performance status - ECOG 0-2 At least 16 weeks Granulocyte count at least 1,500/mm^3 Platelet count at least 60,000/mm^3 Hemoglobin at least 10 g/dL 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 Creatinine no greater than 2 mg/dL No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation No active peptic ulcer disease No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) No congenital abnormality (e.g., Fuch's dystrophy) 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 No prior surgical therapy affecting absorption 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (erlotinib hydrochloride)

Arm Description

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

Outcomes

Primary Outcome Measures

Progression-free survival
Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.

Secondary Outcome Measures

Objective response rate
Summarized by estimates and standard errors.
Rate of stable disease
Summarized by estimates and standard errors.
Duration of stable disease
Summarized by Kaplan-Meier curves, from which medians and overall duration of stable disease can be attained.
Time to progression
Summarized by Kaplan-Meier curves, from which medians and time to progression can be attained.
Overall survival
Summarized by Kaplan-Meier curves, from which medians and overall survival can be attained.

Full Information

First Posted
October 3, 2002
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00047333
Brief Title
Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
Official Title
A Phase 2 Open-Label Study Of OSI-774 (NSC 718781) In Unresectable Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
August 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description
PRIMARY OBJECTIVES: I. To assess progression-free survival (PFS) measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma. SECONDARY OBJECTIVES: I. To assess objective response rate, rate and duration of stable disease, time to progression, median and overall survival in this patient population, and any changes in tumor perfusion based on functional CT imaging. II. To correlate response with patient characteristics including: age, disease stage (TNM, Okuda [6]), viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, Performance Status, serum values of: alpha feto-protein, bilirubin, transaminases, albumin; EGFR expression score by IHC; and development of skin rash during therapy. III. To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population. IV. To determine the safety and tolerability of OSI-774 in this patient population. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (erlotinib hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, erlotinib, OSI-774
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Summarized by Kaplan-Meier curves, from which medians and progression-free survival can be attained.
Time Frame
Time from initiation of therapy until documented disease progression, assessed at 16 weeks
Secondary Outcome Measure Information:
Title
Objective response rate
Description
Summarized by estimates and standard errors.
Time Frame
Up to 4 years
Title
Rate of stable disease
Description
Summarized by estimates and standard errors.
Time Frame
Up to 4 years
Title
Duration of stable disease
Description
Summarized by Kaplan-Meier curves, from which medians and overall duration of stable disease can be attained.
Time Frame
From the start of the treatment until the criteria for progression are met, assessed up to 4 years
Title
Time to progression
Description
Summarized by Kaplan-Meier curves, from which medians and time to progression can be attained.
Time Frame
Up to 4 years
Title
Overall survival
Description
Summarized by Kaplan-Meier curves, from which medians and overall survival can be attained.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Performance status - ECOG 0-2 At least 16 weeks Granulocyte count at least 1,500/mm^3 Platelet count at least 60,000/mm^3 Hemoglobin at least 10 g/dL 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 Creatinine no greater than 2 mg/dL No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation No active peptic ulcer disease No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) No congenital abnormality (e.g., Fuch's dystrophy) 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 No prior surgical therapy affecting absorption 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Thomas
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

We'll reach out to this number within 24 hrs