HAI Via Interventionally Implanted Port Catheter Systems

Colorectal Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00356161
• Other study ID #: CVK-HAI 1
• Status: Recruiting
• Phase: Phase 2
• First received: July 24, 2006
• Last updated: July 24, 2006
• Start date: April 2002
• Est. completion date: April 2008

Study information

• Verified date: July 2006
• Source: Charite University, Berlin, Germany
• Contact: Bert Hildebrandt, MD
• Phone: ++49 30 450 553636
• Email: bert.hildebrandt[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

see above

Exclusion Criteria:

see above

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Cancer
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Colorectal Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Hepatocellular Carcinoma
• Liver Neoplasms
• Neoplasms

Intervention

Device:
• interventionally implanted hepatic arterial port catheter

Locations

Country	Name	City	State
Germany	Charité Centrum Tumormedizin, Medizinische Klinik für Hämatologie und Onkologie, CVK	Berlin
Germany	Klinik für Radiologie und Nuklearmedizin, Otto-von-Guericke Universität Magdeburg	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ricke J, Hildebrandt B, Miersch A, Nicolaou A, Warschewske G, Teichgräber U, Lopez Hänninen E, Riess H, Felix R. Hepatic arterial port systems for treatment of liver metastases: factors affecting patency and adverse events. J Vasc Interv Radiol. 2004 Aug;15(8):825-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of evaluation and intervention group
Primary	Complication rate (device implantation)
Primary	Safety of device and regional therapy
Secondary	prospective evaluation of port duration
Secondary	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)
Secondary	response
Secondary	progression free and overall survival
Secondary	efficacy of maintaining regional therapy combined with systemic chemotherapy in patients with extrahepatic progression while on study
Secondary	quality of life