Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

NCT02456714 | Completed Phase 2

• 1 other identifier: volgt
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma; FOLFIRINOX; Phase II study

Outcome Measures

Primary Outcomes (2)

• pilot study: toxicity

  number of adverse events in accordance with CTCAEv4.0

  24 weeks

• phase II: the response rate

  24 weeks

Secondary Outcomes (8)

• 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.

  24 weeks

Study Arms (1)

Progressive cholangiocarcinoma, second line treatment

EXPERIMENTAL

FOLFIRINOX

Drug: FOLFIRINOX

Interventions

FOLFIRINOX DRUG

Also known as: Second line treatment

Progressive cholangiocarcinoma, second line treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic medical center Amsterdam

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 31919404 DERIVED

Related Links

• Final publication

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

folfirinox

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• H.J. Klümpen, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• J. Wilmink, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: May 28, 2015
• Study Start: May 31, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

NL (1)