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CholangiocarcinomaPhase 24CCNCT02456714

Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

A Phase 2 study testing FOLFIRINOX in people with Cholangiocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cholangiocarcinoma
What is being tested?
FOLFIRINOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
31 May 2016to 1 Dec 2018
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

  • Histological or cytological diagnosis of cholangiocarcinoma.
  • Metastatic disease or irresectable locally advanced cholangiocarcinoma.
  • Measurable disease according RECIST criteria version 1.1.
  • Age from 18 to 75 year.
  • WHO/ECOG performance status 0-2.
  • Patients who received at least 3 cycles of gemcitabine/cisplatin in the first line.
Show all 14Show fewer
  • Adequate hematological function (WBC > 3.0 x 109/L, platelets > 100 x109/L)
  • Adequate hepatic function (bilirubin ≤ 1.5 x upper normal limit (ULN); ALAT or ASAT <5x ULN in case of liver metastases and < 2.5 x ULN in absence of liver metastases.
  • Adequate renal function (creatinine clearance > 60 ml/min; creatinine <120 µmol/L)
  • Absence of cardiac insufficiency, chest pain (not medically controlled) and myocardial infarction in the 12 months preceding study entry.
  • Signed informed consent.
  • Women who are pregnant, breast-feeding or not using adequate contraceptive
  • Age younger than 18 or older than 76 years
  • Individuals under correctional supervision or guardianship

Who cannot join

  • Concurrent secondary malignancies or other malignancies within 3 years prior to enter this study with the exception of non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection
  • Presence of cerebral or meningeal metastases
  • Contraindication to any of the substances of the planned treatment.
  • History of chronic diarrhea or colorectal inflammatory conditions, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
  • Active infection or other serious underlying conditions which may prevent the patient from receiving the planned treatment. For example: prolonged unresolved bacterial cholangitis with destruction of bile duct branches (e.g. after endoprosthesis insertion) or two or more cholangitis in the last 6 months. Patients with other active or uncontrolled severe infection, cirrhosis or chronic active hepatitis will be excluded.
  • Presence of cardiac insufficiency, unstable angina pectoris, symptomatic congestive heart, failure myocardial infarction 6 months prior to randomization, serious uncontrolled cardiac arrhythmia.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academic medical center Amsterdam

    Amsterdam, 1105AZ

Other trials in Netherlands

About this study

Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy.

Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma.

Being tested
FOLFIRINOX
Keywords
Cholangiocarcinoma, FOLFIRINOX, Phase II study
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • FOLFIRINOXDrug

    Also called Second line treatment

Study groups in NCT02456714
Study groupRoleWhat they receive
Progressive cholangiocarcinoma, second line treatmentExperimentalFOLFIRINOX
Receives: Drug: FOLFIRINOX

What is being measured

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

  1. pilot study: toxicity

    number of adverse events in accordance with CTCAEv4.0

    Measured: 24 weeks

  2. phase II: the response rate

    Measured: 24 weeks

Secondary outcomes (8)

  1. pilot study: the response rate

    Measured: 24 weeks

  2. pilot study: time to progression.

    Measured: 24 weeks

  3. pilot study: the overall survival

    Measured: 24 weeks

  4. pilot study: quality of life

    Measured: 24 weeks

  5. phase II: toxicity during the treatment period and 30 days after the treatment.

    number of adverse events in accordance with CTCAEv4.0

    Measured: 24 weeks

  6. phase II: time to progression.

    Measured: 24 weeks

  7. phase II: the overall survival.

    Measured: 24 weeks

  8. phase II: quality of life

    Measured: 24 weeks

Timeline

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

  1. First posted28 May 2015 (estimated)
  2. Study start31 May 2016
  3. Primary completion1 Oct 2018
  4. Study completion1 Dec 2018

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02456714
Sponsor's protocol ID
volgt
Acronym
4CC
Status last verified
Mar 2020
First submitted
10 Mar 2015
Last updated
10 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Belkouz A, de Vos-Geelen J, Mathot RAA, Eskens FALM, van Gulik TM, van Oijen MGH, Punt CJA, Wilmink JW, Klumpen HJ. Efficacy and safety of FOLFIRINOX as salvage treatment in advanced biliary tract cancer: an open-label, single arm, phase 2 trial. Br J Cancer. 2020 Mar;122(5):634-639. doi: 10.1038/s41416-019-0698-9. Epub 2020 Jan 10.

    PubMed 31919404

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FOLFIRINOX in people with Cholangiocarcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

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 14 inclusion and 6 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 10 Mar 2020. 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 Netherlands. 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?

pilot study: toxicity (time frame: 24 weeks). 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 NCT02456714, 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 10 Mar 2020.

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