NCT00440310

Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases

A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: Light Sciences Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy. Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body.

Detailed description

Randomized, stratified, two arm study: * Litx™ and chemotherapy arm (FOLFOX4 or FOLFIRI) * Chemotherapy only arm (FOLFOX4 or FOLFIRI) For patients who have progressed on FOLFIRI, they will be treated with Litx™ plus FOLFOX4 versus FOLFOX4 alone; and for patients who have progressed on FOLFOX, they will be treated with Litx™ plus FOLFIRI versus FOLFIRI alone. Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter (SLD) (SLD \< 4 cm or SLD ≥4 cm but ≤7.5 cm).

Conditions

• Liver Metastases
• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasm Recurrence, Local

Interventions

Type	Name	Description
DRUG	Talaporfin sodium	LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
PROCEDURE	Percutaneous placement of device in liver metastases	Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
DEVICE	Interstitial light emitting diodes	200 J/cm per Light Source at 20 mW/cm light energy
DRUG	FOLFOX4 regimen	Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
DRUG	FOLFIRI regimen	Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan

Timeline

• Start date: 2007-02-01
• Primary completion: 2011-05-01
• Completion: 2011-10-01
• First posted: 2007-02-27
• Last updated: 2015-08-25
• Results posted: 2015-08-25

Locations

57 sites across 13 countries: Austria, Bosnia and Herzegovina, Croatia, Germany, India, Italy, Latvia, Poland, Romania, Russia, Serbia, Sweden, Ukraine