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Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver

NCT03069950 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-05-21

No results posted yet for this study

Summary

The purpose of this study is to see if patients treated with both regional chemotherapy using the HAI pump and intravenous chemotherapy are able to have their liver tumors removed surgically (resected), versus treatment with only intravenous chemotherapy.

Conditions

  • Colorectal Adenocarcinoma Metastatic to the Liver

Interventions

DRUG

Floxuridine (FUDR)

5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days)

DRUG

Irinotecan (CPT-11)

Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.

DRUG

FLUOROURACIL

5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days)

DRUG

PANITUMUMAB

Panitumumab (6 mg/kg IV over 60 min)

DRUG

DEXAMETHASONE

flat dose of 25 mg on Day 1

DRUG

Leucovorin

Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour)

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Queens Cancer Center of Queens Hospital

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Memorial Sloan Kettering Cancer Center

    lead OTHER

Principal Investigators

  • Andrea Cercek, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2019-05-16
Completion
2019-05-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03069950 on ClinicalTrials.gov