Status:
COMPLETED
Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
Lead Sponsor:
Light Sciences LLC
Conditions:
Liver Metastasis
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on thei...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00083785
Start Date
May 1 2004
Last Update
April 11 2007
Active Locations (1)
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1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101