Clinical trial NCT00868998 (phase 2, status: terminated)
Conditions: biliary cancer
ICD codes: C24.9, C24.8
Drugs: gemcitabine, docetaxel, and capecitabine
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Reason stopped: 
    poor patient accrual
  
Eligibility criteria:

        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