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

NCT00440310 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 483

Last updated 2015-08-25

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Light Sciences Oncology

    lead INDUSTRY

Principal Investigators

  • Sy-Shi Wang, PhD · Light Sciences Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2011-05-31
Completion
2011-10-31

Countries

  • Austria
  • Bosnia and Herzegovina
  • Croatia
  • Germany
  • India
  • Italy
  • Latvia
  • Poland
  • Romania
  • Russia
  • Serbia
  • Sweden
  • Ukraine

Study Locations

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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 NCT00440310 on ClinicalTrials.gov