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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

Primary Purpose

Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Malignant Neoplasm

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
trastuzumab
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Extrahepatic Bile Duct

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California, Norris Comprehensive Cancer Center
  • The University of Texas (UT) MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trastuzumab

Arm 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.

Outcomes

Primary Outcome Measures

Objective Response (Complete and Partial Response)
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
Percentage of participants who have achieved complete response, partial response and stable disease
Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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
Length of time from date of starting treatment that participants are still alive

Full Information

First Posted
May 23, 2007
Last Updated
July 29, 2019
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00478140
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to slow accrual
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
anti-c-erB-2, Herceptin, MOAB HER2
Intervention Description
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
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Objective Response (Complete and Partial Response)
Description
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.
Time Frame
Baseline to 63 days or until disease progression
Secondary Outcome Measure Information:
Title
Disease Control Rate
Description
Percentage of participants who have achieved complete response, partial response and stable disease
Time Frame
Up to 3.5 years
Title
Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Description
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.
Time Frame
Up to 3 years
Title
Overall Survival
Description
Length of time from date of starting treatment that participants are still alive
Time Frame
Up to 3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Kaseb
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California, Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The University of Texas (UT) MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
The University of Texas MD Anderson Cancer Center official website

Learn more about this trial

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

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