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

> **NCT01375816** · PHASE2 · TERMINATED · sponsor: **GERCOR - Multidisciplinary Oncology Cooperative Group** · enrollment: 55 (actual)

## Conditions studied

- Colorectal Cancer

## Interventions

- **DRUG:** FOLFIRI 1-Bevacizumab
- **DRUG:** fluorouracil
- **DRUG:** irinotecan hydrochloride
- **DRUG:** leucovorin calcium
- **DRUG:** liposome-encapsulated irinotecan hydrochloride PEP02
- **DRUG:** Bevacizumab

## Key facts

- **NCT ID:** NCT01375816
- **Lead sponsor:** GERCOR - Multidisciplinary Oncology Cooperative Group
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2011-05
- **Primary completion:** 2014-06
- **Final completion:** 2014-12
- **Target enrollment:** 55 (ACTUAL)
- **Why stopped:** efficacy interim analysis as per protocol
- **Last updated:** 2015-06-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01375816

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01375816, "Liposome-encapsulated Irinotecan Hydrochloride PEP02 or Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil as Second-Line Therapy in Treating Patients With Metastatic Colorectal Cancer". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01375816. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
