GTX Regimen for Biliary Cancers

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the intrahepatic or extrahepatic biliary tract including cholangiocarcinoma, gallbladder cancer and ampullary cancer (ampula of vater).
* Prior therapy with gemcitabine, Xeloda or docetaxel is acceptable if he/she only received and failed one of the 3 drugs.
* Prior experimental drug therapies such as Phase I agents are acceptable.
* Measurable disease: Any mass measurable by RECIST 1.1 parameters by CT or MRI scans of metastatic and primary tumor sites
* Ineligible for other high priority national or institutional studies
* Prior radiation and surgery allowed:

  * 3 weeks since surgery or last chemotherapy
  * 4 weeks since RT
* Non pregnant females with a negative serum β-HCG test within 1 week of starting the study, who are not breast feeding. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
* Clinical Parameters Life expectancy \> 3 months Age ≥ 18 y.o Performance status 0-2 (ECOG) (See Appendix IV) Peripheral Neuropathy must be ≤ grade 1 Able to tolerate oral chemotherapeutic medications
* Required initial laboratory data

CBC with Differential Basic Metabolic Panel (BMP) Liver Function Tests (LFTs) Serum β-HCG (non-menopausal females) Tumor Specific Tests Hepatitis B and C Tests Pulse Oximetry on Room Air \>90%

* Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.

Exclusion Criteria:

* Hypersensitivity: Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
* Prior malignancy in last 5 years other than: curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, DCIS (ductal carcinoma in situ) or early stage (I or II) prostate cancer previously treated with curative intent by radiation and/or surgery and is now cancer free.
* Known serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
* Patients with CNS metastases shall be excluded.
* Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
* Patients with currently active inflammatory bowel disease (ulcerative colitis, Crohn's) or sclerosing cholangitis will be excluded. A history of these IBD's or sclerosing cholangitis is acceptable if the disease is in remission or quiescent.
* Active infection with non-A hepatitis virus (Hepatitis B and C) will be excluded