Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Study Overview
=================
Brief 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, 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.

Official Title
-----------------
Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Conditions
-----------------
Cholangiocarcinoma

Intervention / Treatment
-----------------
* Drug: FOLFIRINOX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. 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. 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 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. Inclusion in another investigational clinical trial 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Progressive cholangiocarcinoma, second line treatment<br>FOLFIRINOX | Drug: FOLFIRINOX<br> <br> * Other names: Second line treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pilot study: toxicity | number of adverse events in accordance with CTCAEv4.0 | 24 weeks | 
| phase II: the response rate |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pilot study: the response rate |  | 24 weeks | 
| pilot study: time to progression. |  | 24 weeks | 
| pilot study: the overall survival |  | 24 weeks | 
| pilot study: quality of life |  | 24 weeks | 
| phase II: toxicity during the treatment period and 30 days after the treatment. | number of adverse events in accordance with CTCAEv4.0 | 24 weeks | 
| phase II: time to progression. |  | 24 weeks | 
| phase II: the overall survival. |  | 24 weeks | 
| phase II: quality of life |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholangiocarcinoma, FOLFIRINOX, Phase II study