Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Condition: Liver Metastases; Colorectal Neoplasms; Neoplasm Metastasis; Neoplasm Recurrence, Local
MeSH terms: Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis; Neoplasms, Second Primary; Liver Neoplasms; Neoplasm Recurrence, Local; Recurrence
Intervention: Talaporfin sodium; Percutaneous placement of device in liver metastases; Interstitial light emitting diodes; FOLFOX4 regimen; FOLFIRI regimen
Intervention description: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).; 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.; 200 J/cm per Light Source at 20 mW/cm light energy; Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin; Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
Intervention MeSH terms: Talaporfin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 483.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver neoplasms; Liver metastases; MCRC; Litx™; LS11; Colorectal cancer with recurrent liver metastases

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.
    

Eligibility criteria:

        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 bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of
             randomization. Use of bevacizumab 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.