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A Clinical Trial Phase II of Calcitriol in Combination With 5-fluorouracil, Mitomycin C and Leucovorin in an Open Label-non-randomized Study to Evaluate the Tumor Response in Patients With Advanced Intrahepatic Cholangiocarcinoma


Phase 2
30 Years
65 Years
Not Enrolling
Both
Advanced Intrahepatic Cholangiocarcinoma

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Trial Information

A Clinical Trial Phase II of Calcitriol in Combination With 5-fluorouracil, Mitomycin C and Leucovorin in an Open Label-non-randomized Study to Evaluate the Tumor Response in Patients With Advanced Intrahepatic Cholangiocarcinoma


- OUTLINE: This is a dose-limiting toxicity study of calcitriol.

- EVALUAITON: During the initial phase, 14 patients will be accrued for this study. If
the number of patient's response to calcitriol and 5-fluorouracil/mitomycin
C/leucovorin is less than 1/14, the study will be stopped. However there is one patient
who responses to calcitriol and 5-fluorouracil/mitomycin C/leucovorin, the new 14
patients will be accrued during the secondary phase of study.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.

Outcome Time Frame:

3-6 months

Safety Issue:

Yes

Principal Investigator

Vajarabhongsa Bhudisawasdi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University

Authority:

Thailand: Khon Kaen University Ethics Committee for Human Research

Study ID:

P-09-00171

NCT ID:

NCT01039181

Start Date:

January 2010

Completion Date:

October 2012

Related Keywords:

  • Advanced Intrahepatic Cholangiocarcinoma
  • Vitamin D
  • Calcitriol
  • cholangiocarcinoma
  • Clinical trial
  • Cholangiocarcinoma
  • Liver Neoplasms

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