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Biliary Tract CancerPhase 2NCT01494363

Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

A Phase 2 study testing Fluorouracil, Leucovorin and Oxaliplatin in people with Biliary Tract Cancer, run by Soon Chun Hyang University at 3 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. Goals The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan in patients with locally advanced or metastatic Biliary tract cancer as first-line chemotherapy Secondary goals are to: evaluate the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Fluorouracil, Leucovorin and Oxaliplatin
Type of treatment
Injection or infusion
How many people
53 participants
Where
3 sitesSouth Korea
Study dates
Oct 2011to Dec 2013
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who were diagnosed as adenocarcinoma of gallbladder or biliary tract histologically or cytologically
  • Unresectable locally advanced, metastatic, or recurrent biliary tract cancer
  • Patients must be ≥ 18 , ≤ 75 years old of age
  • ECOG performance status ≤ 2
  • At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Estimated life expectancy of more than 3 months
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  • Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)
  • Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])
  • Adequate liver function (serum total bilirubin < 3.0xULN; serum transaminases levels < 5.0xUNL)
  • Provision of fully informed consent prior to any study specific procedures

Who cannot join

  • Other tumor type than adenocarcinoma
  • Any previous history of chemotherapy for biliary tract cancer (prior neoadjuvant/adjuvant chemotherapy is allowed, if recurrence occurred more than 6 months after completion of previous chemotherapy)
  • Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
  • Patients who received radiotherapy on target lesion within 6 months prior to study treatment
  • Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
  • Patients who received major surgery within 4 weeks of starting study treatment or was not recovered from any effects of major surgery
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  • Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
  • Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites, 3 recruiting

  • Hyun Jung Kim

    Bucheon-si

    Hyun Jung Kim, M.D., +82-32-621-5114, khjbless@schmc.ac.kr

    Recruiting

  • Han Jo Kim

    Cheonan

    Han Jo Kim, M.D., +82-41-570-3693, hzmd@schmc.ac.kr

    Recruiting

  • Nam Su Lee

    Seoul

    Nam Su Lee, M.D., +82-2-709-9114, mdnslee@schmc.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Multicenter Phase II Study of Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) in Patients With Locally Advanced or Metastatic Biliary Tract Cancer

  1. Goals The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan in patients with locally advanced or metastatic Biliary tract cancer as first-line chemotherapy Secondary goals are to: evaluate the treatment-related toxicities of this combination, investigate progression-free survival(PFS) and overall survival(OS) in this population
  2. Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluorouracilDrug

    5-fluorouracil 2400 mg/m2 (diluted in 1000 ml of 5% dextrose solution) administered as a continuous intravenous infusion over 48 hours every 2 weeks

  • LeucovorinDrug

    Leucovorin 400 mg/m2 (diluted in 250 ml of 5% dextrose solution) as a 2-hour intravenous infusion every 2 weeks

  • OxaliplatinDrug

    Oxaliplatin 85 mg/m2 (diluted in 250 ml of 5% dextrose solution) given as a 2-hour intravenous infusion every 2 weeks

  • IrinotecanDrug

    Irinotecan 150 mg/m2 (diluted in 250 ml of 0.9% normal saline solution) given as a 90-minute intravenous infusion every 2 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Assessment of response will be assessed according to RECIST v1.1 criteria after completion of every two cycles. Evaluation will be conducted by physical examination, X-ray, or CT scan

    Measured: 2 years

Secondary outcomes (3)

  1. Treatment-related toxicities

    Assessment of toxicity will be assessed according to NCI CTCAE version 4.0.

    Measured: 2 years

  2. Progression free survival

    Measured: 2 years

  3. Overall survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2013 (estimated)
  4. Study completionDec 2013 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01494363
Sponsor's protocol ID
SCH01
Status last verified
Dec 2011
First submitted
13 Dec 2011
Last updated
19 Dec 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluorouracil, Leucovorin and Oxaliplatin in people with Biliary Tract Cancer, run by Soon Chun Hyang University at 3 sites in South Korea.

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 9 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 2 years). 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 NCT01494363.

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 19 Dec 2011.

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