Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02110953
Other study ID # GI-063
Secondary ID NCI-2014-00706GI
Status Terminated
Phase Phase 1
First received April 8, 2014
Last updated February 22, 2018
Start date January 29, 2016
Est. completion date August 16, 2017

Study information

Verified date April 2017
Source Fox Chase Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial studies the side effects and best dose of irinotecan-eluting beads in treating patients with colon or rectal cancer that has spread to the liver and does not respond to treatment with standard therapy. Irinotecan-eluting beads are tiny beads that have been loaded with irinotecan hydrochloride, a chemotherapy drug. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. This treatment delivers the chemotherapy directly to the tumor area inside the liver instead of to the whole body as with systemic delivery of the drug. Irinotecan-eluting beads may work better that standard chemotherapy in treating patients with colon or rectal cancer that has spread to the liver.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms

Read more »

Intervention

Combination Product:
irinotecan-eluting beads
Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
Procedure:
hepatic artery embolization
Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization

Locations

Country Name City State
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Fox Chase Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose of irinotecan-eluting beads, determined by dose limiting toxicities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 3 weeks
Secondary Response rate, classified using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 8 weeks following administration of irinotecan-eluting beads
Secondary Duration of overall response From the time measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
Secondary Time to progression From start of treatment to progression in the treated lobe, assessed up to 2 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Completed NCT02107755 - Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma Phase 2
Recruiting NCT05057052 - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT04837885 - Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases Phase 2
Terminated NCT04589884 - Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
Not yet recruiting NCT04520737 - Multimodal Prehabilitation During Chemotherapy in Patients With Colorectal Liver Metastases N/A
Terminated NCT02465112 - Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor Phase 3
Completed NCT02352259 - Treatment of Liver Metastases With Electrochemotherapy (ECTJ) Phase II Phase 2
Active, not recruiting NCT01763450 - Bevacizumab Therapy Untreated Unresectable Liver Metastases From Colorectal Cancer Phase 2
Withdrawn NCT01631539 - Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC N/A
Recruiting NCT01250158 - Liver-PILP First-in-Man N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Completed NCT00587756 - Alternative to Two-Stage Hepatectomy N/A
Completed NCT01683357 - Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases N/A
Completed NCT04942665 - Low Dose ICG for Biliary Tract and Tumor Imaging Phase 2
Not yet recruiting NCT05354674 - Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis
Recruiting NCT04616495 - Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases
Not yet recruiting NCT04509635 - Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis Phase 3