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

Phase 2
18 Years
Not Enrolling
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

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Trial Information

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


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


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.


Patients receive trastuzumab IV 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.

Inclusion 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

- 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

- 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 CT scan

- Tumor that recurs within a previously irradiated field is considered measurable
disease if recurrence is documented and measurable by RECIST criteria

- Tumor must be Her2/neu positive by FISH testing

- No symptomatic brain metastases

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- 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 ULN OR creatinine clearance >= 60 mL/min

- No other active malignancy

- LVEF >= 50%

- No concurrent uncontrolled illness

- No ongoing or active infection requiring systemic IV antibiotics on day 1 of

- 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

- WBC >= 3,000/mm^3

- Platelet count >= 40,000/mm^3

- Bilirubin =< 4 mg/dL

- AST and ALT =< 5 times upper limit of normal (ULN)

- Not pregnant or nursing

- Negative pregnancy test

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response (complete and partial response)

Outcome Time Frame:

Up to 4.5 years

Safety Issue:


Principal Investigator

Ahmed Kaseb

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms



M D Anderson Cancer Center Houston, Texas  77030