Clinical trial NCT00478140: Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
Official title: A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-05-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Objective Response (Complete and Partial Response)
timeFrame: Baseline to 63 days or until disease progression
Secondary outcomes:
measure: Disease Control Rate
timeFrame: Up to 3.5 years
measure: Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
timeFrame: Up to 3 years
measure: Overall Survival
timeFrame: Up to 3.5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Houston
country: United States
facility: The University of Texas (UT) MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ahmed Kaseb
role: PRINCIPAL_INVESTIGATOR
References: