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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Metastasis, Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis

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Trial Information

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


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 their tumor characteristics. No more than 4 Light Sources will be used at a
single treatment. The Light Sources may be used in a single lesion or in multiple lesions.

Following radiographic confirmation of Light Source placement, patients will receive an
intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11
administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source
will then be manually removed and the patients will be observed for acute complication of
Light Source removal. Precautions for protection from external light exposure should be
instituted beginning with the LS11 administration and be maintained as defined throughout
the study period. On day 3 following Litx™ treatment the patient will receive a standard
chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for
metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical
assessment and the tumor mass will be imaged using contrast enhanced spiral CT for
determination of volume and radius of PDT necrosis.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

LSC-OL003

NCT ID:

NCT00083785

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Liver Metastasis
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111