Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells.

Clinical Trial Description

OBJECTIVES:

I. Determine the safety and toxicity of hepatic arterial infusion with floxuridine and dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients with surgically resected liver metastases from primary colorectal carcinoma.

II. Determine the 2-year survival rate of patients treated with this regimen. III. Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2.5 years.

PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 9 months-3.25 years. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00026234
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	February 2002

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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms