- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00033462
Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
A Phase II Trial of OSI-774 in Patients With Hepatocellular or Biliary Carcinoma
Study Overview
Status
Conditions
- Advanced Adult Primary Liver Cancer
- Localized Unresectable Adult Primary Liver Cancer
- Recurrent Adult Primary Liver Cancer
- Recurrent Extrahepatic Bile Duct Cancer
- Recurrent Gallbladder Cancer
- Unresectable Extrahepatic Bile Duct Cancer
- Unresectable Gallbladder Cancer
- Adult Primary Hepatocellular Carcinoma
- Cholangiocarcinoma of the Extrahepatic Bile Duct
- Cholangiocarcinoma of the Gallbladder
- Adult Primary Cholangiocellular Carcinoma
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the proportion of patients with unresectable hepatocellular or biliary carcinoma treated with OSI-774 who are progression-free at 24 weeks.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity profile of this treatment in each of the patient groups.
II. To evaluate the objective response rate of patients with hepatocellular or biliary carcinoma treated with OSI-774.
III. To evaluate overall and progression-free survival. IV. To assess the EGFR protein levels and explore their association with clinical outcome.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or biliary carcinoma that is surgically unresectable; exception: for surgically unresectable HCC, a hypervascular mass on CT and an AFP > 100ng/mL will suffice as noninvasive diagnostic criteria
- Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- PLT ≥ 75,000/mm3
- Total bilirubin ≤ 2 x upper normal limits (UNL)
- Serum AST ≤ 3 x UNL
- Serum ALT ≤ 3 x UNL
- Serum creatinine ≤ 2 mg/dL
- Serum albumin ≥ 2.5 g/dL
- Patients not receiving anticoagulation: INR ≤ 1.5
- ECOG performance status (PS) 0, 1, or 2
- Estimated life expectancy ≥ 3 months
- Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide written informed consent
- HCC Patients Only: Child-Pugh classification of A or B
For patients having prior cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy, the following criteria must be met:
- > 6 weeks has elapsed since that therapy
- Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion
- Edges of the indicator lesion are clearly distinct on CT scanning
Exclusion Criteria:
- Ampulla of Vater tumors
Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Breastfeeding women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- NOTE: The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown
Any of the following:
- > 1 prior systemic anticancer therapy; Note: Chemoembolization will be considered as one prior chemotherapeutic regimen.
- Prior EGFR targeting therapy
- Nitrosoureas or mitomycin C ≤6 weeks prior to study entry
Other chemotherapy ≤4 weeks prior to study entry
• Immunotherapy ≤ 4 weeks prior to study entry
- Biologic therapy ≤ 4 weeks prior to study entry
- Radiation therapy ≤ 4 weeks prior to study entry
- Prior cryotherapy, radiofrequency ablation, ethanol injection or photodynamic therapy ≤6 weeks prior to study entry
- Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational
- Major surgery, or significant traumatic injury occurring ≤ 3 weeks prior to planned treatment start date
Any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication
- Requirement for IV alimentation
- Prior procedures affecting absorption
- Active peptic ulcer disease
- History of other malignancy other than hepatocellular or biliary carcinoma within the previous 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervix
Known abnormalities of the cornea such as:
- History of dry eye syndrome or Sjorgen's syndrome
- Congenital abnormality (e.g., Fuch's dystrophy)
- Abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose)
- Abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- Known CNS metastases; NOTE: These patients are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris, cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy; NOTE: Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; these patients are excluded from the study because of possible pharmacokinetic interactions with OSI-774; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
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.
|
Correlative studies
Given orally
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who are progression-free at 24 weeks
Time Frame: At 24 weeks
|
Confidence intervals for the true PFR will be calculated using the methods of Duffy-Santner.
|
At 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to disease progression
Time Frame: Time from registration to documentation of disease progression, assessed up to 3 years
|
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
|
Time from registration to documentation of disease progression, assessed up to 3 years
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Objective response, defined by the RECIST criteria in terms of tumor/lesion size and change
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Overall survival
Time Frame: Time from registration to death due to any cause, assessed up to 3 years
|
The distribution of survival time will be estimated using the method of Kaplan-Meier.
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Time from registration to death due to any cause, assessed up to 3 years
|
EGFR protein levels
Time Frame: Baseline
|
We will evaluate these EGFR protein levels and explore their association with clinical outcome.
|
Baseline
|
Overall response rate in EGFR positive patients
Time Frame: Up to 3 years
|
Analyses will be done independently on patients from each patient group.
Corresponding 95% confidence intervals will also be calculated.
|
Up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip Philip, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Digestive System Neoplasms
- Liver Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Bile Duct Diseases
- Biliary Tract Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Recurrence
- Cholangiocarcinoma
- Liver Neoplasms
- Gallbladder Neoplasms
- Bile Duct Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- NCI-2012-02797
- N01CM17104 (U.S. NIH Grant/Contract)
- MC0152
- 5429
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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