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Adenocarcinoma of the Extrahepatic Bile DuctPhase 2NCT00478140

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

A Phase 2 study testing trastuzumab and laboratory biomarker analysis in people with Adenocarcinoma of the Extrahepatic Bile Duct and Adenocarcinoma of the Gallbladder, run by National Cancer Institute (NCI) at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
trastuzumab and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesUnited States
Study dates
May 2007to Nov 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The University of Texas (UT) MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: A Phase II Study Trastuzumab (NSC 688097) in Her2/Neu Positive Cancer of the Gallbladder or Biliary Tract (NCI 7756)

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

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
trastuzumab, laboratory biomarker analysis
Medical subject headings
Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • trastuzumabBiological

    Also called anti-c-erB-2, Herceptin, MOAB HER2

    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 analysisOther

    Correlative studies

Study groups in NCT00478140
Study groupRoleWhat they receive
TrastuzumabExperimentalParticipants 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.
Receives: Biological: trastuzumab; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 63 days or until disease progression

Secondary outcomes (3)

  1. Disease Control Rate

    Percentage of participants who have achieved complete response, partial response and stable disease

    Measured: Up to 3.5 years

  2. 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.

    Measured: Up to 3 years

  3. Overall Survival

    Length of time from date of starting treatment that participants are still alive

    Measured: Up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionNov 2011
  4. Study completionNov 2011

Why it stopped: Due to slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00478140
Sponsor's protocol ID
NCI-2009-00217
Other IDs
2006-0851, N01CM62202
Status last verified
Jul 2019
First submitted
23 May 2007
Last updated
20 Aug 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trastuzumab and laboratory biomarker analysis in people with Adenocarcinoma of the Extrahepatic Bile Duct and Adenocarcinoma of the Gallbladder, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (Complete and Partial Response) (time frame: Baseline to 63 days or until disease progression). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00478140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.

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