Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
28 participants
INTERVENTIONAL
2010-01-31
2012-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
65 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
National Science and Technology Development Agency, Thailand
OTHER_GOV
Responsible Party
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Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
Principal Investigators
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Vajarabhongsa Bhudisawasdi, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
Locations
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Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Vajarabhongsa Bhudisawasdi, MD
Role: primary
Sopit Wongkham, PhD
Role: backup
References
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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.
Other Identifiers
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P-09-00171
Identifier Type: -
Identifier Source: org_study_id