Biliary Tract DiseasePhase 2NCT00201305
Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
A Phase 2 study testing Gemcitabine+5FU+Leucovorin in people with Biliary Tract Disease, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Biliary Tract Disease
- What is being tested?
- Gemcitabine+5FU+Leucovorin
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2002to Aug 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven carcinoma of the biliary tract, including gallbladder carcinoma and cholangiocarcinoma. The disease should be either locally advanced to the extent that curative surgery is impossible or with documented distant metastasis.
- Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography (CT) scan).
- Age > 18 years. For patients older than 70 years of age, detailed evaluation of the organ function reserves must be done before enrollment unto protocol treatment.
- Karnofsky performance status> 60%
- Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/ml, absolute neutrophil count (ANC)> 1,500/ml, platelet> 150,000/ml.
- Liver transaminases <5 times upper normal limits; total bilirubin <3 mg/dl; serum creatinine < 1.5 mg/dl
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- Serum triglyceride level >70 mg/dl
- No prior cytotoxic chemotherapy. Previous radiotherapy is allowed if the treatment was completed at least 6 weeks before the enrollment onto this study.
- Patients of childbearing age should have effective contraception during the study period.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.
Who cannot join
- Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
- Patients who refuse port-A catheter implantation
- Patients with brain or leptomeningeal metastases.
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
- Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
- Life expectancy less than 2 months.
- Pregnant or nursing women may not participate. Women or men with reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Patients who have previous malignancy except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Phase II Randomized Trial-Weekly Gemcitabine Plus High-Dose 5-Fluorouracil/ Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The primary endpoint is patients' response and the secondary endpoints are chemotherapy-related toxicity, time to disease progression and overall survival. .
Read the detailed description
5-FU has been the mainstay of chemotherapeutic agents for gastrointestinal malignancies. The use of weekly 24-hour infusion of HDFL produces high clinical response in a variety of cancers, including colorectal, gastric and breast cancers, with minimal chemotherapy-related toxicity. Gemcitabine is a synthesized deoxycytidine analogue that is metabolized to dFdCTP in tumor cells and results in inhibition of DNA synthesis and depletion of normal cellular nucleotide pool. It has been shown to be active in the treatment of pancreatic cancer and non-small cell lung cancer. Since the biliary tract and the pancreas share a common embryonic origin and cancers from both sites are characterized by resistance to most chemotherapeutic agents, we postulate that gemcitabine may also be effective for cancer of the biliary tract. In our institution we have devised a regimen of weekly gemcitabine and 24-hour infusion of HDFL for patients with advanced or metastatic pancreatic adenocarcinoma. In 18 evaluable patients, 2 achieved a partial response and 3 minor response. The median duration of response was 4 months and the treatment-related toxicity was acceptable.
The eligibility criteria are patients with advanced or metastatic carcinoma of the biliary tract who are not candidates for curative surgical treatment; good performance status; no prior chemotherapy; clinical measurable tumor; good organ function and good compliance. Each cycle of chemotherapy consists of 4 weeks. On days 1, 8 and 15, gemcitabine will be given by 30-minute intravenous infusion and 5-FU and leucovorin by 24-hour continuous intravenous infusion. The dose of gemcitabine will be 1000 mg/m2. The doses of 5-FU will be 2000 mg/m2 and leucovorin, 300 mg/m2. Treatment will continue until disease progresses or prohibitive toxicity develops. For patients with complete response (CR), chemotherapy will continue for 3 additional courses after the documentation of CR. Estimated time for patient accrual is 3 years.
- Conditions
- Biliary Tract Disease
- Being tested
- Gemcitabine+5FU+Leucovorin
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine+5FU+LeucovorinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the response rate of weekly gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for patients with advanced or metastatic biliary tract cancer.
Secondary outcomes (5)
To determine:
1.Toxicity profile of gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for advanced or metastatic biliary tract cancer.
2.Time to disease progression
3.Overall survival
4.Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2002
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Changhua Christian Hospital, China Medical University Hospital, Mackay Memorial Hospital, Chi Mei Medical Hospital, Taipei Veterans General Hospital, Taiwan, National Cheng-Kung University Hospital, National Taiwan University Hospital
- Investigators
- Ann-Li Cheng, PHD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201305
- Sponsor's protocol ID
- T3202
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 1 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Randomized Trial-Weekly Gemcitabine Plus High-Dose 5-Fluorouracil/ Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
- ClinicalTrials.gov ID
- NCT00201305
- Acronym / sponsor ID
- T3202
- Conditions
- Biliary Tract Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Changhua Christian Hospital, China Medical University Hospital, Mackay Memorial Hospital, Chi Mei Medical Hospital, Taipei Veterans General Hospital, Taiwan, National Cheng-Kung University Hospital, National Taiwan University Hospital
- Study start
- Jul 2002
- Study completion
- Aug 2012
- First posted
- 20 Sep 2005 (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.
This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The primary endpoint is patients' response and the secondary endpoints are chemotherapy-related toxicity, time to disease progression and overall survival. .
Detailed description
5-FU has been the mainstay of chemotherapeutic agents for gastrointestinal malignancies. The use of weekly 24-hour infusion of HDFL produces high clinical response in a variety of cancers, including colorectal, gastric and breast cancers, with minimal chemotherapy-related toxicity. Gemcitabine is a synthesized deoxycytidine analogue that is metabolized to dFdCTP in tumor cells and results in inhibition of DNA synthesis and depletion of normal cellular nucleotide pool. It has been shown to be active in the treatment of pancreatic cancer and non-small cell lung cancer. Since the biliary tract and the pancreas share a common embryonic origin and cancers from both sites are characterized by resistance to most chemotherapeutic agents, we postulate that gemcitabine may also be effective for cancer of the biliary tract. In our institution we have devised a regimen of weekly gemcitabine and 24-hour infusion of HDFL for patients with advanced or metastatic pancreatic adenocarcinoma. In 18 evaluable patients, 2 achieved a partial response and 3 minor response. The median duration of response was 4 months and the treatment-related toxicity was acceptable.
The eligibility criteria are patients with advanced or metastatic carcinoma of the biliary tract who are not candidates for curative surgical treatment; good performance status; no prior chemotherapy; clinical measurable tumor; good organ function and good compliance. Each cycle of chemotherapy consists of 4 weeks. On days 1, 8 and 15, gemcitabine will be given by 30-minute intravenous infusion and 5-FU and leucovorin by 24-hour continuous intravenous infusion. The dose of gemcitabine will be 1000 mg/m2. The doses of 5-FU will be 2000 mg/m2 and leucovorin, 300 mg/m2. Treatment will continue until disease progresses or prohibitive toxicity develops. For patients with complete response (CR), chemotherapy will continue for 3 additional courses after the documentation of CR. Estimated time for patient accrual is 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven carcinoma of the biliary tract, including gallbladder carcinoma and cholangiocarcinoma. The disease should be either locally advanced to the extent that curative surgery is impossible or with documented distant metastasis.
- Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography (CT) scan).
- Age > 18 years. For patients older than 70 years of age, detailed evaluation of the organ function reserves must be done before enrollment unto protocol treatment.
- Karnofsky performance status> 60%
- Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/ml, absolute neutrophil count (ANC)> 1,500/ml, platelet> 150,000/ml.
Key exclusion criteria (8 listed)
- Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
- Patients who refuse port-A catheter implantation
- Patients with brain or leptomeningeal metastases.
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
- Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
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 |
|---|---|---|
| Gemcitabine+5FU+Leucovorin | Drug | – |
Primary outcome
To determine the response rate of weekly gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for patients with advanced or metastatic biliary tract cancer.
5 secondary outcomes
To determine:
1.Toxicity profile of gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for advanced or metastatic biliary tract cancer.
2.Time to disease progression
3.Overall survival
4.Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2009.
- Related InfoLink provided by the sponsor.
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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.
Ann-Li Cheng, PHD study chair
National Taiwan University Hospital
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 Gemcitabine+5FU+Leucovorin in people with Biliary Tract Disease, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 10 inclusion and 8 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: finished, as of the sponsor's last update on 1 Apr 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the response rate of weekly gemcitabine plus high-dose 5-FU/leucovorin chemotherapy for patients with advanced or metastatic biliary tract cancer.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2009.