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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00478140
First received: May 23, 2007
Last updated: May 15, 2014
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
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
Biological: trastuzumab
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective Response (Complete and Partial Response) [ Time Frame: Baseline to 63 days or until disease progression ] [ Designated as safety issue: No ]
    Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.


Secondary Outcome Measures:
  • Disease Control Rate [ Time Frame: Up to 3.5 years ] [ Designated as safety issue: No ]
    Percentage of participants who have achieved complete response, partial response and stable disease

  • Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record.

  • Overall Survival [ Time Frame: Up to 3.5 years ] [ Designated as safety issue: No ]
    Length of time from date of starting treatment that participants are still alive


Enrollment: 4
Study Start Date: May 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: 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.
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478140

Locations
United States, California
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Texas
The University of Texas (UT) MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Ahmed Kaseb M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00478140     History of Changes
Other Study ID Numbers: NCI-2009-00217, 2006-0851, N01CM62202
Study First Received: May 23, 2007
Results First Received: September 17, 2013
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014