Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Gastrointestinal Cancer
About this trial
This is an interventional treatment trial for Cholangiocarcinoma of the Extrahepatic Bile Duct
Eligibility Criteria
Criteria: Absolute neutrophil count >= 1,500/mm3 Histologically or cytologically confirmed cholangiocarcinoma or gallbladder carcinoma: Metastatic or surgically unresectable disease Measurable disease, defined as >= 1 lesion whose longest diameter can be accurately measured as >= 2.0 cm with conventional techniques or as > 1.0 cm with spiral CT scan: Spiral CT scan imaging must be used for pre- and post-treatment tumor measurements of lesions measuring >= 1.0 cm to < 2.0 cm Clinical lesions will only be considered measurable when they are superficial Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung No ampulla of Vater tumors No evidence of CNS disease Life expectancy >= 3 months ECOG performance status 0-2 Platelet count >= 75,000/mm3 Total bilirubin =< 2 times ULN ALT and AST =< 2.5 times ULN Creatinine =< 2 mg/dL Albumin >= 2.5 g/dL Alkaline phosphatase =< 5 times ULN Urine protein:creatinine ratio < 1.0 OR 24-hour urine protein < 1000 mg No concurrent illness or medical condition, including any of the following: Impairment of gastrointestinal (GI) function or disease that may significantly alter the absorption of erlotinib hydrochloride Requirement for IV alimentation No concurrent illness or medical condition, including any of the following: Active peptic ulcer disease; Serious or nonhealing wound, ulcer, or bone fracture; GI bleed that required procedural intervention within the past 3 months No concurrent illness or medical condition, including any of the following: Abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days Ongoing or active infection Symptomatic congestive heart failure Psychiatric illness or social situation that would limit study compliance No other malignancy within the past 3 years No abnormalities of the cornea Not pregnant or nursing Fertile patients must use effective contraception No clinically significant cardiovascular disease More than 4 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered No significant traumatic injury within the past 28 days No prior systemic anticancer therapy for metastatic gallbladder or bile duct cancer More than 28 days since prior major surgery [Note: Insertion of a vascular access device is not considered major/minor surgery] More than 2 weeks since prior minor surgery [Note: Insertion of a vascular access device is not considered major/minor surgery] More than 7 days since prior core biopsy No concurrent major surgery No other concurrent chemotherapy, immunotherapy, radiotherapy, or any other therapy or supportive care considered investigational No concurrent enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer, such as rifampin or Hypericum perforatum No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents or other concurrent anticancer therapies No concurrent prophylactic hematopoietic colony-stimulating factors Concurrent full-dose anticoagulants allowed provided PT/INR is > 1.5 and both of the following criteria are met: In-range INR on a stable dose of oral anticoagulant OR on a stable dose of low molecular weight heparin AND (continued from above) No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels, gastrointestinal ulcerations, or known varices)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Bevacizumab and Erlotinib Hydrochloride
Patients receive 5 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15 and 150 mg oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.