Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
1 other identifier
interventional
25
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 2, 2004
CompletedFirst Posted
Study publicly available on registry
June 3, 2004
CompletedApril 11, 2007
April 1, 2007
June 2, 2004
April 10, 2007
Conditions
Interventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (2)
Lustig RA, Vogl TJ, Fromm D, Cuenca R, Alex Hsi R, D'Cruz AK, Krajina Z, Turic M, Singhal A, Chen JC. A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors. Cancer. 2003 Oct 15;98(8):1767-71. doi: 10.1002/cncr.11708.
PMID: 14534895BACKGROUNDChen J, Keltner L, Christophersen J, Zheng F, Krouse M, Singhal A, Wang SS. New technology for deep light distribution in tissue for phototherapy. Cancer J. 2002 Mar-Apr;8(2):154-63. doi: 10.1097/00130404-200203000-00009.
PMID: 11999949BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2004
First Posted
June 3, 2004
Study Start
May 1, 2004
Last Updated
April 11, 2007
Record last verified: 2007-04