Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

Advanced Intrahepatic Cholangiocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01039181
• Other study ID #: P-09-00171
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 22, 2009
• Last updated: December 23, 2009
• Start date: January 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2009
• Source: National Science and Technology Development Agency, Thailand
• Contact: Vajarabhongsa Bhudisawasdi, MD
• Phone: 66-43-348393
• Email: JOEVAJARA[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Intrahepatic Cholangiocarcinoma
• Cholangiocarcinoma
• Liver Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
National Science and Technology Development Agency, Thailand	Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.		3-6 months	Yes
Primary	To assess quality of life (QOL) of patients who are received calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.		3-6 months	Yes
Secondary	To assess the response of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin in patients with advanced intrahepatic cholangiocarcinoma.		3-6 months	Yes