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


Tracking Information

Start Date  ICMJEFebruary 2007
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
Progression free survival [ Time Frame: 180 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE 
 (submitted: February 23, 2007)
Progression free survival
Change HistoryComplete list of historical versions of study NCT00440310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: June 10, 2008)
Overall survival [ Time Frame: 180 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: February 23, 2007)
Overall survival

Descriptive Information

Brief Title  ICMJEPhase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Official Title  ICMJEA 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
Brief Summary

The purpose of the study is to assess the progression free survival and overall 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, Snoqualmie, 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).

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Liver Metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
Intervention  ICMJE
  • 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 OR FOLFIRI regimen
    Standard care chemotherapy regimens
Study Arms / Comparison Groups
  • Litx + Chemotherapy: Experimental
    Interventions:
    • Drug: Talaporfin sodium
    • Procedure: Percutaneous placement of device in liver metastases
    • Device: Interstitial light emitting diodes
    • Drug: FOLFOX4 OR FOLFIRI regimen
  • Chemotherapy alone: Active Comparator
    Intervention: Drug: FOLFOX4 OR FOLFIRI regimen

Recruitment Information

Estimated Enrollment  ICMJE450
Estimated Completion DateDecember 2009
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI
  • Biopsy proven evidence of colorectal cancer
  • At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed)
  • ECOG Performance Status 0-2
  • Life expectancy of at least 16 weeks
  • At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0
  • Understanding and ability to sign written informed consent
  • 18 years of age or more
  • Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils >1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ; Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN

Exclusion Criteria:

  • Patients who are candidates for complete surgical resection
  • Patients who received bevacizimab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizimab or cetuximab is prohibited while participating in this study
  • Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment).
  • Patients who have a single measurable tumor greater than 7.5 cm in any organ
  • Target lesions irradiated within 3 months of randomization
  • Patients with tumor involvement in greater than 50% of parenchyma of the liver
  • Evidence of major vessel invasion of any organ
  • Patients with any non-colorectal cancers except for adequately treated basal or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for ≥ 3 years, or other cancer from which the patient has been disease-free for ≥ 5 years
  • Known sensitivity to porphyrin-type drugs or known history of porphyria
  • Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study
  • Concurrent participation in another clinical trial involving experimental treatment
  • Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJEAustria,   Bosnia and Herzegovina,   Croatia,   Germany,   India,   Italy,   Latvia,   Poland,   Romania,   Russian Federation,   Serbia,   Sweden,   Ukraine

Administrative Information

NCT ID  ICMJENCT00440310
Responsible PartySy-Shi Wang/Study Director, Light Sciences Oncology, Inc.
Study ID Numbers  ICMJELSO-OL006
Study Sponsor  ICMJELight Sciences Oncology
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Sy-Shi Wang, PhDLight Sciences Oncology
Information Provided ByLight Sciences Oncology