MedTrace Logo

Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

NCT01039181 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2009-12-24

No results posted yet for this study

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.

Conditions

  • Advanced Intrahepatic Cholangiocarcinoma

Interventions

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).

Sponsors & Collaborators

  • Khon Kaen University

    collaborator OTHER

  • National Science and Technology Development Agency, Thailand

    lead OTHER_GOV

Principal Investigators

  • Vajarabhongsa Bhudisawasdi, MD · Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01039181 on ClinicalTrials.gov