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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Light Sciences LLC
• Treatments: Talaporfin

Criteria

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)