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Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083785
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : April 11, 2007
Information provided by:
Light Sciences LLC

Tracking Information
First Submitted Date  ICMJE June 2, 2004
First Posted Date  ICMJE June 3, 2004
Last Update Posted Date April 11, 2007
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00083785 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
Official Title  ICMJE Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
Brief Summary The purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.
Detailed Description

Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions.

Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Metastasis
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: Talaporfin sodium (LS11)
  • Device: LED-based light infusion device
  • Device: Light emitting diodes (LED)
  • Procedure: Photodynamic therapy
  • Procedure: Phototherapy
  • Procedure: Chemotherapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with metastatic liver lesions from colorectal disease
  • Biopsy proven evidence of colorectal cancer
  • Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter
  • Age greater than or equal to 18 years
  • Patients must be able to sign informed consent
  • Life expectancy greater than or equal to 3 months
  • ECOG performance status 0-2
  • Patients with extrahepatic disease in addition to their hepatic metastases may be eligible
  • Must have recovered from the toxicity from any prior antineoplastic therapy

Exclusion Criteria:

  • Patients who are candidates for complete surgical resection
  • Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment
  • Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study
  • PT or PTT greater than 1.5X control
  • Platelet count less than 100,000
  • WBC less than 2500/mm
  • Neutrophils less than 2000/mm
  • Hemoglobin less than 9 g/dL
  • Liver enzymes (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN
  • Total bilirubin greater than 1.5 X ULN
  • Serum creatinine greater than 2.5 X ULN
  • Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00083785
Other Study ID Numbers  ICMJE LSC-OL003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Light Sciences LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Light Sciences LLC
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP