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Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

Primary Purpose

Advanced Intrahepatic Cholangiocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

Thailand

Study Type

Interventional

Intervention

Calcitriol

About this trial

This is an interventional treatment trial for Advanced Intrahepatic Cholangiocarcinoma focused on measuring Vitamin D, Calcitriol, cholangiocarcinoma, Clinical trial

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01039181

First Posted

December 22, 2009

Last Updated

December 23, 2009

Sponsor

National Science and Technology Development Agency, Thailand

Collaborators

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT01039181

Brief Title

Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2011 (Anticipated)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Science and Technology Development Agency, Thailand

Collaborators

Khon Kaen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Intrahepatic Cholangiocarcinoma

Keywords

Vitamin D, Calcitriol, cholangiocarcinoma, Clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Calcitriol

Other Intervention Name(s)

vitamin D

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Time Frame

3-6 months

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vajarabhongsa Bhudisawasdi, MD

Phone

66-43-348393

JOEVAJARA@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sopit Wongkham, PhD

Phone

66-43-348386

Sopit@kku.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vajarabhongsa Bhudisawasdi, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vajarabhongsa Bhudisawasdi, MD

Phone

66-43-348393

JOEVAJARA@gmail.com

First Name & Middle Initial & Last Name & Degree

Sopit Wongkham, PhD

Phone

66-43-348386

Sopit@kku.ac.th

First Name & Middle Initial & Last Name & Degree

Vajarabhongsa Bhudisawasdi, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23480759

Citation

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.

Results Reference

derived

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