Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
Completed · Phase 2
Conditions studied: Liver Metastasis, Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis
In brief
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.
Key facts
- Study ID
- NCT00083785
- Run by
- Light Sciences LLC
- People needed
- 25
- Starts
- 2004-05-01
- Last updated by the study team
- 2007-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Virginia Mason Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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