Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

NCT01039181 | Unknown Phase 2 DMC

• 1 other identifier: P-09-00171
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Intrahepatic Cholangiocarcinoma

Keywords

Vitamin D; Calcitriol; cholangiocarcinoma; Clinical trial

Outcome Measures

Primary Outcomes (2)

• To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.

  3-6 months

• To assess quality of life (QOL) of patients who are received calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.

  3-6 months

Secondary Outcomes (1)

• To assess the response of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin in patients with advanced intrahepatic cholangiocarcinoma.

  3-6 months

Interventions

Calcitriol DRUG

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).

Also known as: vitamin D

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Science and Technology Development Agency, Thailand: lead
• Khon Kaen University: collaborator

Study Sites (1)

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• 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.

  PMID: 23480759 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Calcitriol; Vitamin D

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Vajarabhongsa Bhudisawasdi, MD

  Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vajarabhongsa Bhudisawasdi, MD

CONTACT

66-43-348393; JOEVAJARA@gmail.com

Sopit Wongkham, PhD

CONTACT

66-43-348386; Sopit@kku.ac.th

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 24, 2009

Record last verified: 2009-12

Locations

TH (1)