Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

Inclusion Criteria:

1. Proven histological or cytological diagnosis of advanced intrahepatic cholangiocarcinoma (stage III, IV); Patients are ineligible for surgery.
2. Patients must have measurable or evaluable disease.
3. Age between 30-65 years
4. Performance status must be ECOG 0-1.
5. No prior use of chemotherapy or palliative radiation
6. Tumor size by CT scan must be larger than 10 mm.x10 mm.
7. Life expectancy of at least 12 weeks.
8. Adequate bone marrow, hepatic, and renal function, as evidenced by the following: WBC > 3.0 x 109/L, neutrophils > 1.5 x 109 /L; platelet count > 100 x 109/L; Hct > 30%; total bilirubin < 1 mg/dL; Liver enzymes (alkaline phosphatase, AST, ALT) < 3 times the upper limit of the normal range. Creatinine within the normal range.
9. Female patients must not be pregnant; they must be post-menopausal or practicing an accepted form of birth control. If pregnancy is a possibility, a pregnancy test will be required prior to initiation of therapy.
10. Patients must be accessible for treatment and follow-up.
11. Patient and investigator signed study-specific consent form, indicating the investigational nature of the study.

Exclusion Criteria:

1. Known hypersensitivity to Vitamin D, 5-fluorouracil, mitomycin C
2. Hypercalcemia (patients with corrected serum calcium > 10.5 mg/dL) and hyperparathyroid
3. History of renal/bladder stones
4. History of nephrectomy
5. 30 days prior to study entry, CT scan or ultrasound shows renal/bladder stones.
6. Patients with congestive heart failure or arrhythmia or unstable angina within 6 months prior study
7. Pregnancy/Lactation
8. Palliative radiation or adjuvant therapy or chemotherapy in tumor area
9. No other concurrent malignancies
10. No active infection
11. Metastasis at central nervous system
12. Metastasis at Bone
13. Renal insufficiency (creatinine > 1.5 mg/dL)
14. Patients who are in other concurrent cancer clinical trial