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Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases

This study is currently recruiting participants.
Verified by Light Sciences Oncology, November 2008

Sponsored by: Light Sciences Oncology
Information provided by: Light Sciences Oncology
ClinicalTrials.gov Identifier: NCT00440310
  Purpose

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
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

MedlinePlus related topics:   Cancer    Colorectal Cancer    Liver Cancer   

Drug Information available for:   Monoaspartyl chlorin e6    Talaporfin sodium   

U.S. FDA Resources

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

Further study details as provided by Light Sciences Oncology:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 180 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 180 weeks ] [ Designated as safety issue: No ]

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
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
Chemotherapy alone: Active Comparator Drug: FOLFOX4 OR FOLFIRI regimen
Standard care chemotherapy regimens

Detailed Description:

Randomized, stratified, two arm study:

  • Litx™ and chemotherapy arm (FOLFOX4 or FOLFIRI)
  • Chemotherapy only arm (FOLFOX4 or FOLFIRI)

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with recurrent metastatic liver lesions from colorectal cancer who progressed on either FOLFOX or FOLFIRI
  • Biopsy proven evidence of colorectal cancer
  • At least one liver lesion that can be measured in one dimension at >10 mm with spiral CT scan (CT preferred but MRI allowed)
  • ECOG Performance Status 0-2
  • Life expectancy of at least 16 weeks
  • At least 30 days must have elapsed since the completion of any prior antineoplastic therapy and the patient must have recovered from acute side effects before day 0
  • Understanding and ability to sign written informed consent
  • 18 years of age or more
  • Adequate hematologic, liver and renal functions as evidenced by the following: WBC > 2.5 × 10^9/L ; Platelet Count > 100 × 10^9/L ; Hemoglobin > 90 g/L ; Neutrophils >1.5 × 10^9/L ; PT and PTT < 1.5 Control ; SGOT, SGPT < 5 × ULN ; GGT < 5 × ULN ; Alkaline phosphatase < 5 × ULN ; Bilirubin < 3 × ULN ; Creatinine < 1.5 × ULN

Exclusion Criteria:

  • Patients who are candidates for complete surgical resection
  • Patients who received bevacuzimab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacuzimab or cetuximab is prohibited while participating in this study
  • Patients who would require more than a total number of 12 light source applications over three Litx™ experimental treatments (no more than 4 light sources per treatment).
  • Patients who have a single measurable tumor greater than 7.5 cm in any organ
  • Target lesions irradiated within 3 months of randomization
  • Patients with tumor involvement in greater than 50% of parenchyma of the liver
  • Evidence of major vessel invasion of any organ
  • Patients with any non-colorectal cancers except for adequately treated basal or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient has been disease-free for ≥ 3 years, or other cancer from which the patient has been disease-free for ≥ 5 years
  • Known sensitivity to porphyrin-type drugs or known history of porphyria
  • Pregnancy or breast-feeding patients. A negative pregnancy test (urine or serum) from women of childbearing age is required prior to enrollment. A fertile patient must use effective contraception during participation in the study
  • Concurrent participation in another clinical trial involving experimental treatment
  • Any concurrent disease or condition that in the opinion of the investigator impairs the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440310

Locations
Austria
Landeskrankenhaus Feldkirch     Recruiting
      Feldkirch, Austria
      Contact: Alois Lang, MD         alois.lang@lkhf.at    
      Principal Investigator: Alois Lang, MD            
Bosnia and Herzegovina
Clinical Centre of the University of Sarajevo, Institute of Oncology     Recruiting
      Sarajevo, Bosnia and Herzegovina
      Contact: Semir Bešlija, MD         onkokcus@bih.net.ba    
      Principal Investigator: Semir Bešlija, MD            
Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology     Recruiting
      Mostar, Bosnia and Herzegovina
      Contact: Milenko Bevanda, D.Sci         daniela.bevanda@tel.net.ba    
      Principal Investigator: Milenko Bevanda, D.Sci            
Croatia
University Hospital Dubrava     Recruiting
      Zagreb, Croatia
      Contact: Zeljko Cabrijan, MD         zeljko.cabrijan@zg.t-com.hr    
      Principal Investigator: Milan Kujundži, MD, PhD            
Clinical Centre Zagreb, Clinical Oncology     Recruiting
      Zagreb, Croatia
      Contact: Zdenko Krajina, MD         zdenko.krajina@gmail.com    
      Principal Investigator: Zdenko Krajina, MD            
Germany
Martin-Luther-Universität Halle-Wittenberg     Recruiting
      Halle, Germany
      Contact: Dirk Arnold, MD         dirk.arnold@medizin.uni-halle.de    
      Principal Investigator: Dirk Arnold, MD            
Johann Wolfgang Goethe Universitat     Recruiting
      Frankfurt, Germany
      Contact: Thomas Vogl, MD         t.vogl@em.uni-frankfurt.de    
      Principal Investigator: Thomas Vogl, MD            
Italy
Azienda Ospedaliero-Universitaria Riunti     Recruiting
      Ancona, Italy
      Contact: Stefano Cascinu, MD         s.cascinu@ao-umbertoprimo.marche.it    
      Principal Investigator: Stefano Cascinu, MD            
Azienda Ospedaliera Universitaria Padovana     Recruiting
      Padova, Italy
      Contact: Fabio Farinati, MD         fabio.farinati@unipd.it    
      Principal Investigator: Fabio Farinati, MD            
Latvia
Riga Eastern Hospital, Latvian Oncology Center     Recruiting
      Riga, Latvia
      Contact: Krumins Viesturs, MD         viesturs@onkoc.mt.lv    
      Principal Investigator: Krumins Viesturs, MD            
Poland
Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej     Recruiting
      Łódź, Poland
      Contact: Anna Płużańska, MD         apluzanska@o2.pl    
      Principal Investigator: Anna Płużańska, MD            
Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego     Recruiting
      Warszawa, Poland
      Contact: Marek Nowacki, MD         dyrektor@coi.waw.pl    
      Principal Investigator: Marek Nowacki, MD            
Klinika Chirurgii Ogólnej i Onkologicznej     Recruiting
      Szczecin, Poland
      Contact: Józef Kładny, MD         jkladny@sci.pam.szczecin.pl    
      Principal Investigator: Józef Kładny, MD            
Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej     Recruiting
      Kraków, Poland
      Contact: Jan Kulig, MD         mskulig@cyf-kr.edu.pl    
      Principal Investigator: Jan Kulig, MD            
Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie     Recruiting
      Kraków, Poland
      Contact: Janusz Rolski, MD         cht-krak@wp.pl    
      Principal Investigator: Janusz Rolski, MD            
Klinika Chirurgii Onkologicznej     Recruiting
      Lublin, Poland
      Contact: Wojciech Polkowski, MD         wojciech.polkowski@am.lublin.pl    
      Principal Investigator: Wojciech Polkowski, MD            
Romania
St. Spiridon University Emergency Hospital     Recruiting
      Iasi, Romania
      Contact: Tarcoveanu Eugen, MD         etarco@iasi.mednet.ro    
      Principal Investigator: Tarcoveanu Eugen, MD            
Fundeni Clinical Institute     Recruiting
      Bucharest, Romania
      Contact: Irinel Popescu, MD         irinel.popescu@icfundeni.ro    
      Principal Investigator: Irinel Popescu, MD            
Oncology Institute "Ion Chircuta" Cluj-Napoca     Recruiting
      Timisoara, Romania
      Contact: Ciuleanu Tudor-Eliade, MD, PhD         tudor@iocn.ro    
      Principal Investigator: Ciuleanu Tudor-Eliade, MD, PhD            
County Emergency Hospital Timisoara     Recruiting
      Timisoara, Romania
      Contact: Ioan Sporea, MD         isporea@excite.com    
      Principal Investigator: Ioan Sporea, MD            
Serbia
Institute of Oncology and Radiology of Serbia     Recruiting
      Belgrade, Serbia
      Contact: Dusanka Jelecanin         jelecanind@ncrc.ac.yu    
      Principal Investigator: Ivan Popov, MD            
Institute of Oncology     Recruiting
      Sremska Kamenica, Serbia
      Contact: Matejasev Stanka         matejasev.stanka@onko.onk.ns.ac.yu    
      Principal Investigator: Dusan Jovanovic, MD, PhD            
Military Medical Academy     Recruiting
      Belgrade, Serbia
      Contact: Radoje Doder, MD         doder@eunet.yu    
      Principal Investigator: Radoje Doder, MD            
Slovakia
St. Elizabeth Cancer Institute     Recruiting
      Bratislava, Slovakia
      Contact: Stanislav Špánik, MD         sspanik@ousa.sk    
      Principal Investigator: Stanislav Špánik, MD            
Sweden
Karolinska University Hospital     Recruiting
      Stockholm, Sweden
      Contact: Ake Andren-Sandberg, MD         ake.andren-sandberg@karolinska.se    
      Principal Investigator: Ake Andren-Sandberg, MD            

Sponsors and Collaborators
Light Sciences Oncology

Investigators
Study Director:     Sy-Shi Wang, PhD     Light Sciences Oncology    
  More Information


Responsible Party:   Light Sciences Oncology, Inc. ( Sy-Shi Wang/Study Director )
Study ID Numbers:   LSO-OL006
First Received:   February 23, 2007
Last Updated:   November 4, 2008
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

Keywords provided by Light Sciences Oncology:
Liver neoplasms  
Liver metastases  
MCRC  
Litx™
LS11
Colorectal cancer with recurrent liver metastases

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Liver neoplasms
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Monoaspartyl chlorin e6
Liver Neoplasms
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Neoplasm Recurrence, Local
Colorectal Neoplasms
Hepatocellular carcinoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2008




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