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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:
ClinicalTrials.gov Identifier:
NCT00478140
First Posted: May 24, 2007
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ahmed Kaseb M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00478140     History of Changes
Other Study ID Numbers: NCI-2009-00217
2006-0851
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: May 23, 2007
First Posted: May 24, 2007
Results First Submitted: September 17, 2013
Results First Posted: November 19, 2013
Last Update Posted: May 28, 2014
Last Verified: September 2013

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
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


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