Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 2

Conditions: Recurrent Extrahepatic Bile Duct Cancer; Malignant Neoplasm; Adenocarcinoma of the Extrahepatic Bile Duct; Recurrent Gallbladder Cancer; Adenocarcinoma of the Gallbladder; Unresectable Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer

Treatments: Other: laboratory biomarker analysis; Biological: trastuzumab

Study type: Interventional

Funder types: NIH

Identifiers

NCT00478140

NCI-2009-00217

N01CM62202 (U.S. NIH Grant/Contract)

2006-0851

Details and patient eligibility

About

This phase II trial is studying how well trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them

Full description

PRIMARY OBJECTIVE:

I. Determine the objective response rate and duration of objective response in patients with HER2/neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab (Herceptin).

SECONDARY OBJECTIVES:

I. Assess the safety and tolerability of this drug in these patients. II. Assess the progression-free survival and overall survival of patients treated with this drug.

OUTLINE:

Patients receive trastuzumab intravenously over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Criteria:

• Adenocarcinoma of the gallbladder
• Recurrent extrahepatic bile duct cancer
• Recurrent gallbladder cancer
• Unresectable extrahepatic bile duct cancer
• Adenocarcinoma of the extrahepatic bile duct
• Unresectable gallbladder cancer
• Prior surgery and radiotherapy allowed
• At least 28 days since prior chemotherapy (6 weeks for nitrosoureas and mitomycin C) and recovered
• No other concurrent investigational agents, chemotherapy, radiotherapy, or hormonal therapy
• Concurrent hormones administered for nondisease-related conditions (e.g., insulin for diabetes) allowed
• No concurrent corticosteroids or anticonvulsants
• Concurrent steroids administered for antiemesis, adrenal failure, or septic shock allowed
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct, meeting all of the following criteria: locally advanced or metastatic disease that is unresectable
• Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral computed tomography (CT) scan
• Tumor that recurs within a previously irradiated field is considered measurable disease if recurrence is documented and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• Tumor must be Her2/neu positive by Fluorescence in situ hybridization (FISH)testing
• No symptomatic brain metastases
• The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Absolute neutrophil count (ANC) >= 1,500/mm^3
• Fertile patients must use effective contraception prior to, during, and for >= 3 months after completion of study treatment
• Creatinine =< 2 times upper limits of normal (ULN) OR creatinine clearance >= 60 mL/min
• No other active malignancy
• Left Ventricular Ejection Fraction (LVEF) >= 50%
• No concurrent uncontrolled illness
• No ongoing or active infection requiring systemic IV antibiotics on day 1 of treatment
• No symptomatic New York Heart Association class III-IV congestive heart failure
• No unstable angina pectoris
• No unstable cardiac arrhythmia requiring medication
• No more than 1 prior systemic chemotherapy regimen
• White Blood Count (WBC) >= 3,000/mm^3
• Platelet count >= 40,000/mm^3
• Bilirubin =< 4 mg/dL
• Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =< 5 times upper limit of normal (ULN)
• Not pregnant or nursing
• Negative pregnancy test

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Trastuzumab

Experimental group

Description:

Participants receive trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: laboratory biomarker analysis

Biological: trastuzumab