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

NCT ID: NCT00478140

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-11-30

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab

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.

Group Type: EXPERIMENTAL

trastuzumab

Intervention Type: BIOLOGICAL

For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

trastuzumab

For HER-2/neu positive biopsies, trastuzumab was administered intravenously, once every 3 weeks, at a loading first dose at 8 mg/kg over 90 minutes, and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose.

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

anti-c-erB-2; Herceptin; MOAB HER2

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Kaseb

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, United States

The University of Texas (UT) MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

The University of Texas MD Anderson Cancer Center official website

Other Identifiers

2006-0851

Identifier Type: -

Identifier Source: secondary_id

N01CM62202

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00217

Identifier Type: -

Identifier Source: org_study_id