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Sponsored by: |
Light Sciences Oncology |
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Information provided by: | Light Sciences Oncology |
ClinicalTrials.gov Identifier: | NCT00440310 |
The purpose of the study is to assess the progression free survival and overall survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy.
Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Snoqualmie, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body.
Condition | Intervention | Phase |
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Liver Metastases Colorectal Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local |
Drug: Talaporfin sodium Procedure: Percutaneous placement of device in liver metastases Device: Interstitial light emitting diodes Drug: FOLFOX4 OR FOLFIRI regimen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Multinational Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Treating Colorectal Cancer Patients With Recurrent Liver Metastases Using the Litx™ System Plus Chemotherapy as Compared to Chemotherapy Only |
Estimated Enrollment: | 450 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Litx + Chemotherapy: Experimental |
Drug: Talaporfin sodium
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Procedure: Percutaneous placement of device in liver metastases
Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.
Device: Interstitial light emitting diodes
200 J/cm per Light Source at 20 mW/cm light energy
Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens
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Chemotherapy alone: Active Comparator |
Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens
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Randomized, stratified, two arm study:
For patients who have progressed on FOLFIRI, they will be treated with Litx™ plus FOLFOX4 versus FOLFOX4 alone; and for patients who have progressed on FOLFOX, they will be treated with Litx™ plus FOLFIRI versus FOLFIRI alone.
Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter (SLD) (SLD <4 cm or SLD ≥4 cm but ≤7.5 cm).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Sy-Shi Wang, PhD | Light Sciences Oncology |
Responsible Party: | Light Sciences Oncology, Inc. ( Sy-Shi Wang/Study Director ) |
Study ID Numbers: | LSO-OL006 |
Study First Received: | February 23, 2007 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00440310 |
Health Authority: | United States: Food and Drug Administration; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Croatia: Ministry of Health and Social Care; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Bosnia: Federal Ministry of Health; Latvia: State Agency of Medicines; Slovakia: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Italy: The Italian Medicines Agency; Romania: National Medicines Agency; Sweden: Medical Products Agency; Austria: Federal Office for Safety in Health Care; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health |
Liver neoplasms Liver metastases MCRC |
Litx™ LS11 Colorectal cancer with recurrent liver metastases |
Liver Diseases Digestive System Neoplasms Talaporfin Gastrointestinal Diseases Colonic Diseases Liver neoplasms Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Liver Neoplasms Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Neoplasm Recurrence, Local Colorectal Neoplasms |
Photosensitizing Agents Disease Attributes Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |