Safety and Efficacy of Treating Refractory Cancers With the Litx™ System: Phase II Safety and Efficacy Study in Patients With Liver Metastases From Colorectal Cancer That Have Failed Chemotherapy
18 Years
N/A
Both
Liver Metastasis, Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis
Trial Information
Safety and Efficacy of Treating Refractory Cancers With the Litx™ System: Phase II Safety and Efficacy Study in Patients With Liver Metastases From Colorectal Cancer That Have Failed Chemotherapy
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 infusion
devices depending on their tumor characteristics. No more than 4 light sources will be used
at a single treatment. The light infusion devices may be used in a single lesion or in
multiple lesions.
Following radiographic confirmation of light infusion device placement, patients will
receive an intravenous dose of LS11 at 40 mg/m². One hour following completion of LS11
administration, delivery of 200 J/cm light energy will begin. The light infusion device
will then be manually removed and the patients will be observed for acute complication of
light infusion device 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 30+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 the tumor size, as well as tumor necrosis. The patient may then receive 5-FU
and/or leucovorin + either irinotecan or oxaliplatin standard chemotherapy at day 30 visit.
All patients, with or without chemotherapy at day 30, will undergo final clinical assessment
and final tumor imaging evaluation using contrast CT at day 60+5 of Litx treatment.
Inclusion Criteria
Inclusion Criteria
- Patients with metastatic liver lesions from colorectal disease who have failed or
progressed on a chemotherapy regimen for metastatic 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 are
eligible and will receive systemic therapy for their extrahepatic disease following
Litx therapy.
- Off chemotherapy for 4 weeks. Must have recovered from the chemotherapy effects.
Exclusion Criteria
Patients must be excluded if any of the following apply:
- 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 greater than 3 X ULN.
- Total bilirubin greater than 1.5 X ULN.
- Serum creatinine greater than 2.5 X ULN.
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-OL002
NCT ID:
NCT00068068
Start Date:
October 2003
Completion Date:
Related Keywords:
- Liver Metastasis
- Colorectal Neoplasms
- Liver Neoplasms
- Neoplasm Metastasis
- Photodynamic therapy
- Liver metastases
- Colorectal cancer
- Litx™
- Light Infusion Technology™
- Talaporfin sodium
- LS11
- Liver mets
- Metastatic colorectal cancer
- Light emittting diodes (LED)
- Tumor ablation
- Combination therapy
- Neoplasms
- Colorectal Neoplasms
- Liver Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
Name | Location |
|---|---|
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania 15212-4772 |
| HealthOne Alliance/Presbyterian St. Lukes Medical Center | Denver, Colorado 80218 |
| Eastern Carolina University, School of Medicine | Greenville, North Carolina 27858 |
| University of Pennsylvania / Department of Radiation Oncology | Philadelphia, Pennsylvania 19104 |
