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

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).

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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

You may not be if

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.

What this study is about