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Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT01039181
Recruitment Status : Unknown
Verified December 2009 by National Science and Technology Development Agency, Thailand.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Intrahepatic Cholangiocarcinoma Drug: Calcitriol Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2012


Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin. [ Time Frame: 3-6 months ]
  2. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039181


Contacts
Contact: Vajarabhongsa Bhudisawasdi, MD 66-43-348393 JOEVAJARA@gmail.com
Contact: Sopit Wongkham, PhD 66-43-348386 Sopit@kku.ac.th

Locations
Thailand
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University Not yet recruiting
Khon Kaen, Thailand, 40002
Contact: Vajarabhongsa Bhudisawasdi, MD    66-43-348393    JOEVAJARA@gmail.com   
Contact: Sopit Wongkham, PhD    66-43-348386    Sopit@kku.ac.th   
Principal Investigator: Vajarabhongsa Bhudisawasdi, MD         
Sponsors and Collaborators
National Science and Technology Development Agency, Thailand
Khon Kaen University
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vajarabhongsa Bhudisawasdi, Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01039181     History of Changes
Other Study ID Numbers: P-09-00171
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009

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

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vitamins
Vitamin D
Calcitriol
Fluorouracil
Mitomycins
Mitomycin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents