Liver MetastasesPhase 3NCT00440310
Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
A Phase 3 study testing Talaporfin sodium, Percutaneous placement of device in liver metastases and Interstitial light emitting diodes in people with Liver Metastases and Colorectal Neoplasms, run by Light Sciences Oncology at 57 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Colorectal Neoplasms, Neoplasm Metastasis
- What is being tested?
- Talaporfin sodium, Percutaneous placement of device in liver metastases and Interstitial light emitting diodes
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 57 sitesin 13 countries
- Study dates
- Feb 2007to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
Russia11 sites
State Institution "Altay" Territorial Oncological Dispensary
Barmaul
Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation
Moscow
Municipal Cliical Hospital # 33 named after Ostroumov
Moscow
Russian Oncological Scientific Center named after Blokhin
Moscow
Privolzhsky District Medical Center
Nizhny Novgorod
Central Research Institute of Roentgenology and Radiology
Saint Petersburg
Scientific Research Institution of Oncology
Saint Petersburg
State Educational Institution of High Professional Education "Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia"
Saint Petersburg
Tambov Regional Oncological Dispensary
Tambov
State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"
Yaroslavl
State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"
Yekaterinburg
India8 sites
Bangalore Institute of Oncology
Bangalore, Karnataka
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal
CIIGMA Institute of Medical Sciences
Chhatrapati Sambhajinagar
SEAROC Cancer Center, S. K. Soni hospital
Jaipur
Shatabdi Super Specialty Hospital
Mumbai
Cancer Clinic, Shreevardhan complex
Nagpur
Mahavir Cancer Sansthan
Phulwarisharif, Patna
Ruby Hall Clinic
Pune
Poland7 sites
Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie
Krakow
Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej
Krakow
Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej
Lodz
Klinika Chirurgii Onkologicznej
Lublin
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii
Olsztyn
Klinika Chirurgii Ogólnej i Onkologicznej
Szczecin
Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego
Warsaw
Ukraine6 sites
Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy
Cherkassy
Municipal Multiple-Discipline Clinical Hospital #4
Dnipro
Donetsk Cancer Centre
Donetsk
Kharkov Regional Clinical Oncology Dispansery
Kharkiv
The Central Hospital of the Ministry of Defense
Kyiv
Zaporozhye Medical Academy for postgraduate education
Zaporizhzhya
Germany5 sites
Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I
Aalen
Helios Kliniken - Innere Medizin und Kardiologie
Borna
Katholisches Krankenhaus St. Johann Nepomuk
Erfurt
Johann Wolfgang Goethe Universitat
Frankfurt
Kliniken Ludwigsburg Bietigheim
Ludwigsburg
Croatia4 sites
General Hospital Karlovac
Karlovac
Clinical Centre Zagreb, Clinical Oncology
Zagreb
General Hospital "Sveti Duh"
Zagreb
University Hospital Dubrava
Zagreb
Italy4 sites
Azienda Ospedaliero-Universitaria Riunti
Ancona
Azienda Ospedaliera Careggi U.O. Oncologia Medica
Florence
Azienda Ospedaliera Universitaria Padovana
Padova
Policlinico Tor Vergata - Oncologia Medica
Rome
Romania3 sites
Fundeni Clinical Institute
Bucharest
Oncology Institute "Ion Chircuta"
Cluj-Napoca
St. Spiridon University Emergency Hospital
Iași
Serbia3 sites
Institute of Oncology and Radiology of Serbia
Belgrade
Military Medical Academy
Belgrade
Institute of Oncology
Kamenitz
Austria2 sites
Landeskrankenhaus Feldkirch
Feldkirch
Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel
Vienna
Bosnia and Herzegovina2 sites
Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology
Mostar
Clinical Centre of the University of Sarajevo, Institute of Oncology
Sarajevo
About this 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
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.
Read the 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).
- Being tested
- Talaporfin sodium, Percutaneous placement of device in liver metastases, Interstitial light emitting diodes, FOLFOX4 regimen, FOLFIRI regimen
- Keywords
- Liver neoplasms, Liver metastases, MCRC, Litx™, LS11, Colorectal cancer with recurrent liver metastases
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Neoplasm Recurrence, Local, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talaporfin sodiumDrug
LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).
Percutaneous placement of device in liver metastasesProcedure or surgery
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.
Interstitial light emitting diodesDevice
200 J/cm per Light Source at 20 mW/cm light energy
FOLFOX4 regimenDrug
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
FOLFIRI regimenDrug
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan
| Study group | Role | What they receive |
|---|---|---|
| Litx + Chemotherapy | Experimental | Not described Receives: Drug: Talaporfin sodium; Procedure: Percutaneous placement of device in liver metastases; Device: Interstitial light emitting diodes; Drug: FOLFOX4 regimen; Drug: FOLFIRI regimen |
| Chemotherapy alone | Active comparator | Not described Receives: Drug: FOLFOX4 regimen; Drug: FOLFIRI regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from randomization to death
Measured: Up to 184 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- Light Sciences Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sy-Shi Wang, PhD, Study director, Light Sciences Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440310
- Sponsor's protocol ID
- LSO-OL006
- Status last verified
- Jul 2015
- First submitted
- 23 Feb 2007
- Last updated
- 25 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00440310
- Acronym / sponsor ID
- LSO-OL006
- Keywords
- Liver neoplasms, Liver metastases, MCRC, Litx™, LS11, Colorectal cancer with recurrent liver metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Light Sciences OncologyIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Posted 25 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Litx + Chemotherapy | Experimental | Drug: Talaporfin sodium, Procedure: Percutaneous placement of device in liver metastases, Device: Interstitial light emitting diodes, Drug: FOLFOX4 regimen, Drug: FOLFIRI regimen |
| Chemotherapy alone | Active comparator | Drug: FOLFOX4 regimen, Drug: FOLFIRI regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talaporfin sodiumLS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes). | Drug | Litx + Chemotherapy |
| Percutaneous placement of device in liver metastasesLight 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. | Procedure or surgery | Litx + Chemotherapy |
| Interstitial light emitting diodes200 J/cm per Light Source at 20 mW/cm light energy | Device | Litx + Chemotherapy |
| FOLFOX4 regimenStandard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin | Drug | Chemotherapy alone, Litx + Chemotherapy |
| FOLFIRI regimenStandard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan | Drug | Chemotherapy alone, Litx + Chemotherapy |
Primary outcome
Overall Survival
Time frame: Up to 184 weeks
Time from randomization to death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sy-Shi Wang, PhD study director
Light Sciences Oncology
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Talaporfin sodium, Percutaneous placement of device in liver metastases and Interstitial light emitting diodes in people with Liver Metastases and Colorectal Neoplasms, run by Light Sciences Oncology at 57 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Russia, India, Poland, Ukraine, Germany and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Up to 184 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.