Trial record 2 of 95 for:    cholangiocarcinoma | Open Studies | Exclude Unknown | "Cholangiocarcinoma"

Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma (4CC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
Heinz-Josef Klumpen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02456714
First received: March 10, 2015
Last updated: February 11, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Drug: FOLFIRINOX
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • pilot study: toxicity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    number of adverse events in accordance with CTCAEv4.0

  • phase II: the response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pilot study: the response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • pilot study: time to progression. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • pilot study: the overall survival [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • pilot study: quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • phase II: toxicity during the treatment period and 30 days after the treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    number of adverse events in accordance with CTCAEv4.0

  • phase II: time to progression. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • phase II: the overall survival. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • phase II: quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progressive cholangiocarcinoma, second line treatment
FOLFIRINOX
Drug: FOLFIRINOX
Other Name: Second line treatment

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02456714

Contacts
Contact: H Klümpen, MD, PhD 31 20 566 5955 h.klumpen@amc.uva.nl

Locations
Netherlands
Academic medical center Amsterdam Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: H.J. Klumpen, MD    003120566955    trialmedonc@amc.nl   
Principal Investigator: H.J. Klumpen, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: H.J. Klümpen, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair: J. Wilmink, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: Heinz-Josef Klumpen, Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02456714     History of Changes
Other Study ID Numbers: volgt 
Study First Received: March 10, 2015
Last Updated: February 11, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Cholangiocarcinoma
FOLFIRINOX
Phase II study

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 27, 2016