Status:
COMPLETED
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors. Monoclonal antibodies, such...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride. SECONDARY OBJECTIVES:...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00356889
Start Date
May 1 2006
End Date
June 1 2010
Last Update
May 28 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905