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Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer

NCT00361842 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-07-02

Study results available
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Summary

The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection

CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.

Sponsors & Collaborators

Principal Investigators

  • Gerald Batist, MD · Sir Mortimer B. Davis - Jewish General Hospital

  • John Marshall, MD · Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

  • Arthur Louie, MD · Jazz Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00361842 on ClinicalTrials.gov