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Liposome-encapsulated Irinotecan Hydrochloride PEP02 or Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil as Second-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

NCT01375816 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-06-04

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving liposome-encapsulated irinotecan hydrochloride PEP02 together with leucovorin calcium and fluorouracil is more effective than giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well it works compared with giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.

Conditions

Interventions

DRUG

FOLFIRI 1-Bevacizumab

DRUG

fluorouracil

DRUG

irinotecan hydrochloride

DRUG

leucovorin calcium

DRUG

liposome-encapsulated irinotecan hydrochloride PEP02

DRUG

Bevacizumab

Sponsors & Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

    lead OTHER

Principal Investigators

  • Frederique Maindrault-Goebel, MD · Hopital Saint Antoine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01375816 on ClinicalTrials.gov