A Randomized Phase II Study of PEP02 or Irinotecan in Combination With Leucovorin and 5-Fluorouracil in Second Line Therapy of Metastatic Colorectal Cancer (PEPCOL)

NCT01375816 Phase 2 TERMINATED

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.

Details

Lead sponsor	GERCOR - Multidisciplinary Oncology Cooperative Group
Phase	Phase 2
Status	TERMINATED
Enrolment	55
Start date	2011-05
Completion	2014-12

Conditions

• Colorectal Cancer

Interventions

• FOLFIRI 1-Bevacizumab
• fluorouracil
• irinotecan hydrochloride
• leucovorin calcium
• liposome-encapsulated irinotecan hydrochloride PEP02
• Bevacizumab

Primary outcomes

• Tumor response — at 2 months
  Assessment of tumor response at 2 month after randomization by RECIST 1.1

Countries

France