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Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by National Science and Technology Development Agency, Thailand.
Recruitment status was:  Not yet recruiting
Khon Kaen University
Information provided by:
National Science and Technology Development Agency, Thailand Identifier:
First received: December 22, 2009
Last updated: December 23, 2009
Last verified: December 2009
Cholangiocarcinoma (CCA), cancer of the bile duct, is the first cause of cancer death of the people in the northeast of Thailand. The incidence of CCA in this region is highest not only in the country but in the world. CCA is a slow growing but highly metastatic tumor. At present, there is no standard chemotherapy or effective treatment for CCA. Most of the patients have short survival after diagnosis. Strong evidences from in vitro, animal and clinical studies indicate that vitamin D can prevent and control growth of cancer. Our preclinical studies in CCA cell lines, animal and patient tissue culture indicate that vitamin D effectively reduce growth of CCA. Supplementation of vitamin D to chemotherapeutic drugs enhance drug toxicity and better response. At present, there are several clinical trials in USA on supplementation of vitamin D or its analogs to cancer patients. The side effect or toxicity of using vitamin D supplementation is low, some patients had stable disease and some had good response. The current study is set up a clinical trial phase II of vitamin D (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. This study will provide an alternative/effective chemotherapy treatment for CCA patients. Better survival and improved quality of life are also expected.

Condition Intervention Phase
Advanced Intrahepatic Cholangiocarcinoma
Drug: Calcitriol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by National Science and Technology Development Agency, Thailand:

Primary Outcome Measures:
  • To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin. [ Time Frame: 3-6 months ]
  • To assess quality of life (QOL) of patients who are received calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin. [ Time Frame: 3-6 months ]

Secondary Outcome Measures:
  • To assess the response of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin in patients with advanced intrahepatic cholangiocarcinoma. [ Time Frame: 3-6 months ]

Estimated Enrollment: 28
Study Start Date: January 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Calcitriol
    12 mcg Calcitriol will be given orally three times per week for 6 months. In this portion of the study, all patients will get the same dose of calcitriol along with the standard chemotherapy (5-fluorouracil-mitomycin C-leucovorin).
    Other Name: vitamin D
Detailed Description:
  • 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.

Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01039181

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
National Science and Technology Development Agency, Thailand
Khon Kaen University
Principal Investigator: Vajarabhongsa Bhudisawasdi, MD Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vajarabhongsa Bhudisawasdi, Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University Identifier: NCT01039181     History of Changes
Other Study ID Numbers: P-09-00171 
Study First Received: December 22, 2009
Last Updated: December 23, 2009

Keywords provided by National Science and Technology Development Agency, Thailand:
Vitamin D
Clinical trial

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors processed this record on February 20, 2017