| Inclusion Criteria: | 1) Patients must have histologically or cytologically confirmed adenocarcinoma of the gallbladder or bile duct that is locally advanced or metastatic and not amenable to resection.
2) Patient's tumor or biopsy specimen will undergo FISH testing. Only patients whose tumor is Her2/neu positive by FISH testing are eligible.
3) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan. Tumor that recurs within a previously irradiated field can be considered as measurable disease if such recurrence is documented as such in the interpreting diagnostic radiologist's report, and is otherwise measurable per RECIST.
4) Patients may have received prior therapy including surgical resection, radiation therapy (to a total dose of not more than 60 Gy to the abdomen), and/or up to one prior systemic chemotherapy regimen. At least 28 days must have elapsed since completion of prior therapy (6 weeks for nitrosoureas and mitomycin C).
5) Age >/=18 years. Because no dosing or adverse event data are currently available on the use of trastuzumab in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
6) ECOG performance status </= 2 (Karnofsky >/= 60%).
7) Patients must have organ and marrow function as defined as leukocytes >/= 3,000/mcL; absolute neutrophil count >/= 1,500/mcL; platelets >/= 40,000/mcL; total bilirubin </= 4 mg/dL; AST(SGOT) and ALT(SGPT) </= 5.0 X institutional upper limit of Normal (ULN); creatinine </= 2XULN OR creatinine clearance >/= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
8) Ability to understand and the willingness to sign a written informed consent document.
9) The effects of trastuzumab on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because IgG monoclonal antibodies are known to be able to pass the placenta, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and at least 3 months after the last dose. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10) Both men and women and members of all races and ethnic groups are eligible for this trial. |