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

December 22, 2009
December 23, 2009
January 2010
October 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01039181 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Calcitriol in Advanced Intrahepatic Cholangiocarcinoma
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.

  • 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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Intrahepatic Cholangiocarcinoma
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
Not Provided
Sookprasert A, Pugkhem A, Khuntikeo N, Chur-in S, Chamadol N, Prawan A, Janeklang S, Vaeteewoottacharn K, Kukongviriyapan V, Pairojkul C, Bhudhisawasdi V, Wongkham S. Evaluation of efficacy, safety and tolerability of high dose-intermittent calcitriol supplementation to advanced intrahepatic cholangiocarcinoma patients--a pilot study. Asian Pac J Cancer Prev. 2012;13 Suppl:161-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
28
October 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
No
Contact: Vajarabhongsa Bhudisawasdi, MD 66-43-348393 JOEVAJARA@gmail.com
Contact: Sopit Wongkham, PhD 66-43-348386 Sopit@kku.ac.th
Thailand
 
NCT01039181
P-09-00171
Yes
Vajarabhongsa Bhudisawasdi, Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
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
National Science and Technology Development Agency, Thailand
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP