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Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Science and Technology Development Agency, Thailand.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Khon Kaen University
Information provided by:
National Science and Technology Development Agency, Thailand
ClinicalTrials.gov Identifier:
NCT01039181
First received: December 22, 2009
Last updated: December 23, 2009
Last verified: December 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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.
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by National Science and Technology Development Agency, Thailand

Additional 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
Study First Received: December 22, 2009
Last Updated: December 23, 2009
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

Additional relevant MeSH terms:
Cholangiocarcinoma
Liver Neoplasms
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on November 23, 2014