Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

Completed · Phase 2

Conditions studied: Adult Primary Cholangiocellular Carcinoma, Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, 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

In brief

Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.

Key facts

Study ID

NCT00033462

Run by

National Cancer Institute (NCI)

People needed

78

Starts

2002-03-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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