Advanced Intrahepatic CholangiocarcinomaPhase 2NCT01039181
Calcitriol in Advanced Intrahepatic Cholangiocarcinoma
A Phase 2 study testing Calcitriol in people with Advanced Intrahepatic Cholangiocarcinoma, run by National Science and Technology Development Agency, Thailand at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Advanced Intrahepatic Cholangiocarcinoma
- What is being tested?
- Calcitriol
- Type of treatment
- Pill or oral medicine
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2010to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
Vajarabhongsa Bhudisawasdi, MD, 66-43-348393, JOEVAJARA@gmail.com
Sopit Wongkham, PhD, 66-43-348386, Sopit@kku.ac.th
About this study
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
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.
Read the 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.
- Conditions
- Advanced Intrahepatic Cholangiocarcinoma
- Being tested
- Calcitriol
- Keywords
- Vitamin D, Calcitriol, cholangiocarcinoma, Clinical trial
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called vitamin D
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.
Measured: 3-6 months
To assess quality of life (QOL) of patients who are received calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.
Measured: 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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Science and Technology Development Agency, Thailand
- Sponsor type
- Other government
- Collaborators
- Khon Kaen University
- Investigators
- Vajarabhongsa Bhudisawasdi, MD, Principal investigator, Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039181
- Sponsor's protocol ID
- P-09-00171
- Status last verified
- Dec 2009
- First submitted
- 22 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23480759
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01039181
- Acronym / sponsor ID
- P-09-00171
- Conditions
- Advanced Intrahepatic Cholangiocarcinoma
- Keywords
- Vitamin D, Calcitriol, cholangiocarcinoma, Clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- National Science and Technology Development Agency, ThailandOther government
- Collaborators
- Khon Kaen University
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcitriolAlso: vitamin D12 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). | Drug | – |
Primary outcome
To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.
Time frame: 3-6 months
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Derived from this study: PubMed 23480759Sookprasert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vajarabhongsa Bhudisawasdi, MD principal investigator
Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcitriol in people with Advanced Intrahepatic Cholangiocarcinoma, run by National Science and Technology Development Agency, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vajarabhongsa Bhudisawasdi, MD (66-43-348393, JOEVAJARA@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin. (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.