Clinical Trials Logo
  1. Home
  2. Liver Metastases
  3. NCT00645710

Hepatic Arterial Infusion of Floxuridine, Gemcitabine Hydrochloride, and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer Previously Treated With Surgery

Liver Metastases Clinical Trial

Official title:
A Phase I/II Trial of Radioimmunotherapy (Y-90 cT84.66), Gemcitabine and Hepatic Arterial Infusion of Fudr for Metastatic Colorectal Carcinoma to the Liver

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as floxuridine and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry cancer-killing substances directly into the liver. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving hepatic arterial infusion of floxuridine together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase I/II trial is studying the side effects and best dose of floxuridine when given as a hepatic arterial infusion together with gemcitabine hydrochloride and radiolabeled monoclonal antibody therapy and to see how well it works in treating liver metastases in patients with metastatic colorectal cancer.

Clinical Trial Description

OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) and associated toxicities of concurrent hepatic arterial infusion (HAI) fluorodeoxypyrimidine (FUdR)/Decadron and intravenous gemcitabine combined with intravenous yttrium-90 (^90Y) chimeric T84.66 (cT84.66) in colorectal cancer patients after hepatic resection or maximum surgical debulking (to < 3 cm) of liver metastases.

II. To study the feasibility and toxicities of such adjuvant therapy following resection and/or ablation of liver metastases.

III. To evaluate the biodistribution, clearance and metabolism of ^90Y and ^111In (indium-iii) chimeric T84.66 administered intravenously.

IV. To estimate radiation doses to whole body, normal organs, and tumor through serial nuclear imaging.

V. To correlate proteomic profiles pre and post-therapy with toxicities and anti-tumor effects.

OUTLINE: This is a phase I, dose-escalation study of floxuridine followed by a phase II study.

Patients receive floxuridine as a continuous hepatic arterial infusion on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 9 and 11. Patients also receive yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV over 25 minutes on day 9. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients may receive an additional course of floxuridine in combination with systemic therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 3 and 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00645710
Study type Interventional
Source City of Hope Medical Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 11, 2005
Completion date February 7, 2018
View Details
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 NCT01683357 - Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases N/A
Completed NCT00587756 - Alternative to Two-Stage Hepatectomy 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