We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 131 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies | "Cholangiocarcinoma"

Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma (4CC)

This study is currently recruiting participants.
Verified June 2017 by Heinz-Josef Klumpen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02456714
First Posted: May 28, 2015
Last Update Posted: June 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Heinz-Josef Klumpen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
March 10, 2015
May 28, 2015
June 26, 2017
December 2015
January 2018   (Final data collection date for primary outcome measure)
  • pilot study: toxicity [ Time Frame: 24 weeks ]
    number of adverse events in accordance with CTCAEv4.0
  • phase II: the response rate [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT02456714 on ClinicalTrials.gov Archive Site
  • pilot study: the response rate [ Time Frame: 24 weeks ]
  • pilot study: time to progression. [ Time Frame: 24 weeks ]
  • pilot study: the overall survival [ Time Frame: 24 weeks ]
  • pilot study: quality of life [ Time Frame: 24 weeks ]
  • 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
  • phase II: time to progression. [ Time Frame: 24 weeks ]
  • phase II: the overall survival. [ Time Frame: 24 weeks ]
  • phase II: quality of life [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
 
Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma
Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cholangiocarcinoma
Drug: FOLFIRINOX
Other Name: Second line treatment
Experimental: Progressive cholangiocarcinoma, second line treatment
FOLFIRINOX
Intervention: Drug: FOLFIRINOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2018
January 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: H Klümpen, MD, PhD 31 20 566 5955 h.klumpen@amc.uva.nl
Netherlands
 
 
NCT02456714
volgt
No
Not Provided
Not Provided
Heinz-Josef Klumpen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Not Provided
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)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP