Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Phase 2

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Drug: FOLFIRINOX

• Registration Number: NCT02456714
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-28
• Study Start: 2016-05-31
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Progressive cholangiocarcinoma, second line treatment	FOLFIRINOX	FOLFIRINOX

Primary Outcome Measures

Name	Time	Method
pilot study: toxicity	24 weeks	number of adverse events in accordance with CTCAEv4.0
phase II: the response rate	24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Academic medical center Amsterdam; 🇳🇱 Amsterdam, Netherlands