- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01039181
Calcitriol in Advanced Intrahepatic Cholangiocarcinoma
December 23, 2009 updated by: National Science and Technology Development Agency, Thailand
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
28
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vajarabhongsa Bhudisawasdi, MD
- Phone Number: 66-43-348393
- Email: JOEVAJARA@gmail.com
Study Contact Backup
- Name: Sopit Wongkham, PhD
- Phone Number: 66-43-348386
- Email: Sopit@kku.ac.th
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
-
Contact:
- Vajarabhongsa Bhudisawasdi, MD
- Phone Number: 66-43-348393
- Email: JOEVAJARA@gmail.com
-
Contact:
- Sopit Wongkham, PhD
- Phone Number: 66-43-348386
- Email: Sopit@kku.ac.th
-
Principal Investigator:
- Vajarabhongsa Bhudisawasdi, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Proven histological or cytological diagnosis of advanced intrahepatic cholangiocarcinoma (stage III, IV); Patients are ineligible for surgery.
- Patients must have measurable or evaluable disease.
- Age between 30-65 years
- Performance status must be ECOG 0-1.
- No prior use of chemotherapy or palliative radiation
- Tumor size by CT scan must be larger than 10 mm.x10 mm.
- Life expectancy of at least 12 weeks.
- 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.
- 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.
- Patients must be accessible for treatment and follow-up.
- Patient and investigator signed study-specific consent form, indicating the investigational nature of the study.
Exclusion Criteria:
- Known hypersensitivity to Vitamin D, 5-fluorouracil, mitomycin C
- Hypercalcemia (patients with corrected serum calcium > 10.5 mg/dL) and hyperparathyroid
- History of renal/bladder stones
- History of nephrectomy
- 30 days prior to study entry, CT scan or ultrasound shows renal/bladder stones.
- Patients with congestive heart failure or arrhythmia or unstable angina within 6 months prior study
- Pregnancy/Lactation
- Palliative radiation or adjuvant therapy or chemotherapy in tumor area
- No other concurrent malignancies
- No active infection
- Metastasis at central nervous system
- Metastasis at Bone
- Renal insufficiency (creatinine > 1.5 mg/dL)
- Patients who are in other concurrent cancer clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.
Time Frame: 3-6 months
|
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
|
3-6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Vajarabhongsa Bhudisawasdi, MD, Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
October 1, 2012
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
December 23, 2009
First Posted (Estimate)
December 24, 2009
Study Record Updates
Last Update Posted (Estimate)
December 24, 2009
Last Update Submitted That Met QC Criteria
December 23, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Cholangiocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Vitamin D
- Calcitriol
Other Study ID Numbers
- P-09-00171
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Intrahepatic Cholangiocarcinoma
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Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic Cholangiocarcinoma | Oligometastatic Intrahepatic CholangiocarcinomaUnited States
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