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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Chemot

Brief 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 Summary:

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).


Sponsor: Light Sciences Oncology

Current Primary Outcome: Overall Survival [ Time Frame: Up to 184 weeks ]

Time from randomization to death


Original Primary Outcome: Progression free survival

Current Secondary Outcome:

Original Secondary Outcome: Overall survival

Information By: Light Sciences Oncology

Dates:
Date Received: February 23, 2007
Date Started: February 2007
Date Completion:
Last Updated: July 28, 2015
Last Verified: July 2015