HAI Via Interventionally Implanted Port Catheter Systems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00356161
First received: July 24, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

Procedures to provide interventional implantation of a port catheter system into the hepatic artery and adjacent regional chemotherapy of the liver are optimized in the scope of an open, single-arm trial in patients with metastases and cancers confined to the liver. The primary objective is the improvement of indication, implantation procedure, and regional chemotherapy. Secondary objectives are port patency, comparison of complications with a historical collective of patients provided with a surgical hepatic arterial port device (colorectal cancer patients only), progression free and overall survival, efficacy of maintaining regional chemotherapy with 5-FU in combination with systemic treatment in patients with extrahepatic progression, quality of life.


Condition Intervention Phase
Colorectal Cancer
Liver Neoplasms
Hepatocellular Carcinoma
Gallbladder Cancer
Bile Duct Cancer
Device: interventionally implanted hepatic arterial port catheter
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open One-Arm Therapy Optimizing Trial on Regional Chemotherapy of the Liver Through an Interventionally Implanted A.Hepatica Port System in Patients With Liver Metastases or Primary Liver Neoplasms.

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Comparison of evaluation and intervention group
  • Complication rate (device implantation)
  • Safety of device and regional therapy

Secondary Outcome Measures:
  • prospective evaluation of port duration
  • comparison of complication and port duration with an historical collective of patients provided with a surgically implanted hepatic arterial port catheter system (liver metastases of colorectal cancer)
  • response
  • progression free and overall survival
  • efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study
  • quality of life

Estimated Enrollment: 100
Study Start Date: April 2002
Estimated Study Completion Date: April 2008
Detailed Description:

Inclusion criteria:

  • histologically confirmed hepatic cancer without symptomatic extrahepatic manifestation.
  • non-resectable disease or hepatic resection or ablation in between the past 8 weeks.
  • measurable disease (at least before hepatic resection)
  • Karnofsky performance status => 70%, or ECOG status 0-2
  • >18 years of age
  • life expectancy > 6 months
  • compliance of the patient
  • written informed consent

Exclusion criteria:

  • second neoplasia within the past 3 years, except for non-melanotic skin cancer, adequately treated Ca in situ of cervix uteri, or adequately resected second colorectal cancer (in patients with liver metastases of colorectal cancer)
  • symptomatic extrahepatic disease, in particular disseminated bone metastases, brain metastases
  • liver cirrhosis with portal hypertension, active hepatitis B or C, previous percutaneous radiotherapy of the liver
  • active infection
  • history of gastric or duodenal ulcer
  • symptomatic or uncontrolled peripheral arterial occlusive disease, history of stenosis of the renal artery.
  • history of dilatative cardiomyopathy, vitium of mitral or aortic valve, persisting foramen ovale, atrial fibrillation
  • artificial heart valve or vascular
  • history of diabetic microangiopathy
  • uncontrolled hyperthyriodism
  • other severe concomitant disease (heart failure >NYHA 2°, respiratory failure, renal failure >stage2, liver failure (TPZ <50%).
  • inherited or acquired immunodeficiency syndrome
  • contraindication against 5-FU
  • pregnancy and nursing, no contraception
  • limited contractual capability.

After enrollment, an a port catheter catheter system is interventionally implanted into the hepatic artery and the patient is scheduled for regional chemotherapy according one out of 8 pre-defined chemotherapy schedules. All regimens are based on 5-fluorouracil and leucovorin, and optionally contain intraarterial mitomycin, oxaliplatin, or additional intravenous irinotecan.

Patients are followed up and evaluated for primary and secondary endpoints. After the inclusion of 50 patients treated and follow up at our institution, the study population has been extended to 100 patients in 8/2004.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

see above

Exclusion Criteria:

see above

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00356161

Contacts
Contact: Bert Hildebrandt, MD ++49 30 450 553636 bert.hildebrandt@charite.de
Contact: Hanno Riess, MD, PhD ++49 30 450 553112 hanno.riess@charite.de

Locations
Germany
Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK Recruiting
Berlin, Germany, 13344
Contact: Bert Hildebrandt, MD    ++49 30 450 553 636    bert.hildebrandt@charite.de   
Principal Investigator: Annett Nicolaou, MD         
Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg Recruiting
Magdeburg, Germany, 39120
Contact: Maciej Pech, MD    +49 391 67-13030    radiologie@uni-magdeburg.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Chair: Bert Hildebrandt, MD Charté Centrum Tumormedizin, CVK, D-13344 Berlin
Study Chair: Hanno Riess, MD, PhD Charité Centrum Tumormedizin, CVK, D-13344 Berlin
Study Chair: Jens Ricke, MD, PhD Klinik für Radiologie und Nuklearmedizin, Universität Magdeburg, Leipziger Str. 44, D-39120 Magdeburg
Study Chair: Roland Felix, MD, PhD Klinik für Strahlenheilkunde, CVK, Charité Universitätsmedizin Berlin, D-13344 Berlin
Study Chair: Peter Neuhaus, MD, PhD Charité Centrum Chirurgische Medizin, CVK, D-13344 Berlin
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00356161     History of Changes
Other Study ID Numbers: CVK-HAI 1
Study First Received: July 24, 2006
Last Updated: July 24, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
colorectal neoplasms
hepatocellular carcinoma
gallbladder cancer
bile duct cancer
hepatic arterial infusion

Additional relevant MeSH terms:
Bile Duct Neoplasms
Neoplasms
Carcinoma
Colorectal Neoplasms
Liver Neoplasms
Gallbladder Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on April 16, 2014