Second-line chemotherapy FOLFIRINOX in unresectable cholangiocarcinoma

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Histological or cytological diagnosis of cholangiocarcinoma. Histological
diagnosis is needed if a patient wants to participate in the translational
study (see section 11).
- Metastatic disease or unresectable locally advanced
cholangiocarcinoma.
- Measurable disease according RECIST criteria version 1.1.
- Age from 18 up to 75 year.
- ECOG performance status 0-1.
- Patients who received at least 3 cycles of gemcitabine/cisplatin in the
first-line.
- 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.
- Written informed consent.

Exclusion Criteria

- 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
- Hypersensitivity to the active substance of oxaliplatin,
leucoverin,irinotecan and/ or 5-FU or to any of excipients used in these
drugs as described in Summary of Product Characteristics (SPCs).
- History of chronic diarrhea or colorectal inflammatory conditions
- 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 endoprothesis insertion) or two or more periods of
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.
- Patients with peripheral sensory neuropathy with functional
impairment prior to the first cycle of FOLFIRINOX.
- Bone marrow depression after radiotherapy or treatment with other
antineoplastic drugs, defined as baseline values neutrophils <2 x 109 / L
and / or platelets <100 x 109 / L.
- Current iInclusion in another investigational clinical trial of cancer
treatment.
- Patients who use Azole antifungals and/or anti-cancer medication at
inclusion (see section 6.1.6). Patients who use brivudine, sorivudine and
there analogs. Patiënt with concomitant use of St. John's wort
preparations.
- Pernicious anemia or other anaemias due to vitamin B 12 deficiency.
- Males who wish to have children while receiving this chemotherapy or
within 6 months after the end of participation in this study.
- Women who are pregnant, breast-feeding or not using adequate
contraceptive
- Age younger than 18 or older than 75 years
- ECOG performance status >1.
- Incapacitated persons who are not able to provide consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pilot study: toxicity<br /><br>Phase II study: response rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pilot study: response rate, time to progression, overall survival and quality<br /><br>of life.<br /><br>Phase II study: toxicity, especially grade 3 and 4 toxicities, time to<br /><br>progression, overall survival and quality of life.</p><br>