Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive the study drugs
in 21-day study cycles.

You will receive all 3 drugs by vein on Days 1 and 8 of each cycle over about 2 hours total.
You will receive abraxane first, followed by cisplatin, and then gemcitabine.

Study Visits:

On Days 1 and 8 of each cycle:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

At the end of every 3rd cycle (Cycles 3, 6, 9, and so on), you will have MRI or CT scans. If
the disease appears to get better, you will have another scan about 3 cycles later.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after the last scan during long-term follow-up.

End-of-Treatment Visit:

Within 10 days after you stop taking the study drugs:

- You will have a physical exam.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- If you have not had one in the last 4 weeks, you will have MRI or CT scans.

Follow-Up:

About 30 days after your last dose of the study drugs, the study staff will ask about any
symptoms or side effects you may be having, either by phone or during a routine clinic visit.
If you are called, it should last about 15-30 minutes.

Long-Term Follow-Up:

About every 12 weeks after the end-of-treatment visit, if you leave the study for any reason
other than the disease getting worse, you will have an MRI or CT scan to check the status of
the disease. If you start receiving other anti-cancer treatment, you will stop having these
scans.

The study staff will also review your medical records and/or call you to check the status of
the disease every 3 months after you stop receiving the study drugs. If you are called, it
should take about 5 minutes.

Inclusion Criteria:

1. Patient must have histologically or cytologically confirmed intrahepatic
cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer or may
undergo a repeat biopsy for histologic confirmation if pre-existing biopsy is not
sufficient for diagnosis.

2. Metastatic or unresectable disease documented on diagnostic imaging studies.

3. May not have received prior chemotherapy. If patient has received prior adjuvant
therapy, must be > 6 months from treatment.

4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.

5. Adequate organ function including: a) Absolute neutrophil count (ANC) =/>1,500
cells/mm^3; b) Platelets =/>100,000/ul; c) Hemoglobin >9.0 g/dL; d) Total bilirubin
=/<1.5mg/dL (In patients with known Gilbert's syndrome direct bilirubin =/<1.5 x ULN
will be used as organ function criteria, instead of total bilirubin; e) AST and ALT
=/< 5 x ULN; f) Creatinine =/<1.5 gm/dL

6. Negative serum or urine pregnancy test in women with childbearing potential (WOCBP)
defined as not post-menopausal for 12 months or no previous surgical sterilization,
within one week prior to initiation of treatment. WOCBP must be using an adequate
method of contraception to avoid pregnancy throughout the study and for up to 12 weeks
after the last dose of study drug to minimize the risk of pregnancy.

7. A male subject of fathering potential must use an adequate method of contraception to
avoid conception throughout the study and for up to 12 weeks after the last dose of
study drug to minimize the risk of pregnancy. If the partner is pregnant or
breastfeeding, the subject must use a condom.

8. Patients must sign an Informed Consent and Authorization indicating that they are
aware of the investigational nature of this study and the known risks involved.

9. Patient is =/>18 years of age on the day of consenting to the study.

Exclusion Criteria:

1. Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse
Events (CTCAE) 4.0. In CTCAE version 4.0 grade 2 sensory neuropathy is defined as
"moderate symptoms; limiting instrumental activities of daily living (ADLs)"

2. Concurrent severe and/or uncontrolled medical conditions which could compromise
participation in the study such as unstable angina, myocardial infarction within 6
months, unstable symptomatic arrhythmia, uncontrolled diabetes, serious active or
uncontrolled infection.

3. Pregnancy (positive pregnancy test) or lactation.

4. Known CNS disease, except for treated brain metastasis. Treated brain metastases are
defined as having no evidence of progression or hemorrhage after treatment and no
ongoing requirement for dexamethasone, as ascertained by clinical examination and
brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose)
are allowed. Treatment for brain metastases may include whole brain radiotherapy
(WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as
deemed appropriate by the treating physician. Patients with CNS metastases treated by
neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will
be excluded.