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Trial record 2 of 129 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies | "Cholangiocarcinoma"

Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma (4CC)

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ClinicalTrials.gov Identifier: NCT02456714
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: FOLFIRINOX Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma
Study Start Date : December 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Progressive cholangiocarcinoma, second line treatment
Other Name: Second line treatment

Outcome Measures

Primary Outcome Measures :
  1. pilot study: toxicity [ Time Frame: 24 weeks ]
    number of adverse events in accordance with CTCAEv4.0

  2. phase II: the response rate [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. pilot study: the response rate [ Time Frame: 24 weeks ]
  2. pilot study: time to progression. [ Time Frame: 24 weeks ]
  3. pilot study: the overall survival [ Time Frame: 24 weeks ]
  4. pilot study: quality of life [ Time Frame: 24 weeks ]
  5. phase II: toxicity during the treatment period and 30 days after the treatment. [ Time Frame: 24 weeks ]
    number of adverse events in accordance with CTCAEv4.0

  6. phase II: time to progression. [ Time Frame: 24 weeks ]
  7. phase II: the overall survival. [ Time Frame: 24 weeks ]
  8. phase II: quality of life [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456714

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

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)
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
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by Heinz-Josef Klumpen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Phase II study

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