GTX Regimen for Biliary Cancers
Condition: Biliary Cancer
MeSH terms: Biliary Tract Neoplasms
Intervention: Gemcitabine, docetaxel, and capecitabine
Intervention description: Day 1-14: Capecitabine 600 mg/m2/day (maximum dose 2000 mg/m2/day total divided into BID PO doses) Day 4 and 11: Gemcitabine 600 mg/m2 IV over 60 mins Day 4 and 11: Docetaxel 30 mg/m2 IV over 60 mins preceded by 12 mg dexamethasone IV or PO or 4 mg if diabetic
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Biliary Cancer

Summary:

      This is a study for patients with advanced cancer of the biliary tree, such as
      cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of
      Gemcitabine, Taxotere, and Xeloda every 21 days for at least 9 weeks. Treatment will continue
      until their cancer progresses. This chemotherapy regimen has been used in pancreatic cancer
      and there is reason to believe that it will be effective for cancers of the biliary tree as
      well.
    

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