Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Primary Purpose
Liver Metastases, Colorectal Neoplasms, Neoplasm Metastasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Talaporfin sodium
Percutaneous placement of device in liver metastases
Interstitial light emitting diodes
FOLFOX4 regimen
FOLFIRI regimen
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastases focused on measuring Liver neoplasms, Liver metastases, MCRC, Litx™, LS11, Colorectal cancer with recurrent liver metastases
Eligibility 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 bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab 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.
Sites / Locations
- Landeskrankenhaus Feldkirch
- Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel
- Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology
- Clinical Centre of the University of Sarajevo, Institute of Oncology
- General Hospital Karlovac
- Clinical Centre Zagreb, Clinical Oncology
- General Hospital "Sveti Duh"
- University Hospital Dubrava
- Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I
- Helios Kliniken - Innere Medizin und Kardiologie
- Katholisches Krankenhaus St. Johann Nepomuk
- Johann Wolfgang Goethe Universitat
- Kliniken Ludwigsburg Bietigheim
- Bangalore Institute of Oncology
- Mahavir Cancer Sansthan
- CIIGMA Institute of Medical Sciences
- Jawaharlal Nehru Cancer Hospital and Research Centre
- SEAROC Cancer Center, S. K. Soni hospital
- Shatabdi Super Specialty Hospital
- Cancer Clinic, Shreevardhan complex
- Ruby Hall Clinic
- Azienda Ospedaliero-Universitaria Riunti
- Azienda Ospedaliera Careggi U.O. Oncologia Medica
- Azienda Ospedaliera Universitaria Padovana
- Policlinico Tor Vergata - Oncologia Medica
- Riga Eastern Hospital, Latvian Oncology Center
- Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie
- Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej
- Klinika Chirurgii Onkologicznej
- Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii
- Klinika Chirurgii Ogólnej i Onkologicznej
- Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego
- Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej
- Fundeni Clinical Institute
- Oncology Institute "Ion Chircuta"
- St. Spiridon University Emergency Hospital
- State Institution "Altay" Territorial Oncological Dispensary
- State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"
- Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation
- Municipal Cliical Hospital # 33 named after Ostroumov
- Russian Oncological Scientific Center named after Blokhin
- Privolzhsky District Medical Center
- Central Research Institute of Roentgenology and Radiology
- Scientific Research Institution of Oncology
- State Educational Institution of High Professional Education "Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia"
- Tambov Regional Oncological Dispensary
- State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"
- Institute of Oncology and Radiology of Serbia
- Military Medical Academy
- Institute of Oncology
- Karolinska University Hospital
- Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy
- Municipal Multiple-Discipline Clinical Hospital #4
- Donetsk Cancer Centre
- Kharkov Regional Clinical Oncology Dispansery
- The Central Hospital of the Ministry of Defense
- Zaporozhye Medical Academy for postgraduate education
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Litx + Chemotherapy
Chemotherapy alone
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Time from randomization to death
Secondary Outcome Measures
Full Information
NCT ID
NCT00440310
First Posted
February 23, 2007
Last Updated
July 28, 2015
Sponsor
Light Sciences Oncology
1. Study Identification
Unique Protocol Identification Number
NCT00440310
Brief Title
Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Light Sciences Oncology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to assess the overall survival and progression free 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, Bellevue, 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastases, Colorectal Neoplasms, Neoplasm Metastasis, Neoplasm Recurrence, Local
Keywords
Liver neoplasms, Liver metastases, MCRC, Litx™, LS11, Colorectal cancer with recurrent liver metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
483 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Litx + Chemotherapy
Arm Type
Experimental
Arm Title
Chemotherapy alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Talaporfin sodium
Intervention Description
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Intervention Type
Procedure
Intervention Name(s)
Percutaneous placement of device in liver metastases
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Interstitial light emitting diodes
Intervention Description
200 J/cm per Light Source at 20 mW/cm light energy
Intervention Type
Drug
Intervention Name(s)
FOLFOX4 regimen
Intervention Description
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Description
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization to death
Time Frame
Up to 184 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 bevacizumab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacizumab 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sy-Shi Wang, PhD
Organizational Affiliation
Light Sciences Oncology
Official's Role
Study Director
Facility Information:
Facility Name
Landeskrankenhaus Feldkirch
City
Feldkirch
Country
Austria
Facility Name
Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel
City
Wien
Country
Austria
Facility Name
Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology
City
Mostar
Country
Bosnia and Herzegovina
Facility Name
Clinical Centre of the University of Sarajevo, Institute of Oncology
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
General Hospital Karlovac
City
Karlovac
Country
Croatia
Facility Name
Clinical Centre Zagreb, Clinical Oncology
City
Zagreb
Country
Croatia
Facility Name
General Hospital "Sveti Duh"
City
Zagreb
Country
Croatia
Facility Name
University Hospital Dubrava
City
Zagreb
Country
Croatia
Facility Name
Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I
City
Aalen
Country
Germany
Facility Name
Helios Kliniken - Innere Medizin und Kardiologie
City
Borna
Country
Germany
Facility Name
Katholisches Krankenhaus St. Johann Nepomuk
City
Erfurt
Country
Germany
Facility Name
Johann Wolfgang Goethe Universitat
City
Frankfurt
Country
Germany
Facility Name
Kliniken Ludwigsburg Bietigheim
City
Ludwigsburg
Country
Germany
Facility Name
Bangalore Institute of Oncology
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Mahavir Cancer Sansthan
City
Phulwarisharif
State/Province
Patna
Country
India
Facility Name
CIIGMA Institute of Medical Sciences
City
Aurangabad
Country
India
Facility Name
Jawaharlal Nehru Cancer Hospital and Research Centre
City
Bhopal
Country
India
Facility Name
SEAROC Cancer Center, S. K. Soni hospital
City
Jaipur
Country
India
Facility Name
Shatabdi Super Specialty Hospital
City
Mumbai
Country
India
Facility Name
Cancer Clinic, Shreevardhan complex
City
Nagpur
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
Country
India
Facility Name
Azienda Ospedaliero-Universitaria Riunti
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliera Careggi U.O. Oncologia Medica
City
Firenze
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Padovana
City
Padova
Country
Italy
Facility Name
Policlinico Tor Vergata - Oncologia Medica
City
Rome
Country
Italy
Facility Name
Riga Eastern Hospital, Latvian Oncology Center
City
Riga
Country
Latvia
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie
City
Kraków
Country
Poland
Facility Name
Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej
City
Kraków
Country
Poland
Facility Name
Klinika Chirurgii Onkologicznej
City
Lublin
Country
Poland
Facility Name
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii
City
Olsztyn
Country
Poland
Facility Name
Klinika Chirurgii Ogólnej i Onkologicznej
City
Szczecin
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego
City
Warszawa
Country
Poland
Facility Name
Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej
City
Łódź
Country
Poland
Facility Name
Fundeni Clinical Institute
City
Bucharest
Country
Romania
Facility Name
Oncology Institute "Ion Chircuta"
City
Cluj-Napoca
Country
Romania
Facility Name
St. Spiridon University Emergency Hospital
City
Iasi
Country
Romania
Facility Name
State Institution "Altay" Territorial Oncological Dispensary
City
Barmaul
Country
Russian Federation
Facility Name
State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"
City
Ekaterinburg
Country
Russian Federation
Facility Name
Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation
City
Moscow
Country
Russian Federation
Facility Name
Municipal Cliical Hospital # 33 named after Ostroumov
City
Moscow
Country
Russian Federation
Facility Name
Russian Oncological Scientific Center named after Blokhin
City
Moscow
Country
Russian Federation
Facility Name
Privolzhsky District Medical Center
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Central Research Institute of Roentgenology and Radiology
City
St. Petersburg
Country
Russian Federation
Facility Name
Scientific Research Institution of Oncology
City
St. Petersburg
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia"
City
St. Petersburg
Country
Russian Federation
Facility Name
Tambov Regional Oncological Dispensary
City
Tambov
Country
Russian Federation
Facility Name
State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"
City
Yaroslavl
Country
Russian Federation
Facility Name
Institute of Oncology and Radiology of Serbia
City
Belgrade
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
Country
Serbia
Facility Name
Institute of Oncology
City
Sremska Kamenica
Country
Serbia
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy
City
Cherkassy
Country
Ukraine
Facility Name
Municipal Multiple-Discipline Clinical Hospital #4
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Donetsk Cancer Centre
City
Donetsk
Country
Ukraine
Facility Name
Kharkov Regional Clinical Oncology Dispansery
City
Kharkov
Country
Ukraine
Facility Name
The Central Hospital of the Ministry of Defense
City
Kyiv
Country
Ukraine
Facility Name
Zaporozhye Medical Academy for postgraduate education
City
Zaporozhye
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
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