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

Colorectal Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440310
• Other study ID #: LSO-OL006
• Status: Completed
• Phase: Phase 3
• First received: February 23, 2007
• Last updated: July 28, 2015
• Start date: February 2007
• Est. completion date: October 2011

Study information

• Verified date: July 2015
• Source: Light Sciences Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesCroatia: Ministry of Health and Social CarePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsBosnia: Federal Ministry of HealthLatvia: State Agency of MedicinesSlovakia: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyRomania: National Medicines AgencySweden: Medical Products AgencyAustria: Federal Office for Safety in Health CareRussia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthIndia: Drugs Controller General of India
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasm Recurrence, Local
• Neoplasms
• Neoplasms, Second Primary
• Recurrence

Intervention

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 regimen
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin
• FOLFIRI regimen
Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel	Wien
Bosnia and Herzegovina	Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology	Mostar
Bosnia and Herzegovina	Clinical Centre of the University of Sarajevo, Institute of Oncology	Sarajevo
Croatia	General Hospital Karlovac	Karlovac
Croatia	Clinical Centre Zagreb, Clinical Oncology	Zagreb
Croatia	General Hospital "Sveti Duh"	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Germany	Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I	Aalen
Germany	Helios Kliniken - Innere Medizin und Kardiologie	Borna
Germany	Katholisches Krankenhaus St. Johann Nepomuk	Erfurt
Germany	Johann Wolfgang Goethe Universitat	Frankfurt
Germany	Kliniken Ludwigsburg Bietigheim	Ludwigsburg
India	CIIGMA Institute of Medical Sciences	Aurangabad
India	Bangalore Institute of Oncology	Bangalore	Karnataka
India	Jawaharlal Nehru Cancer Hospital and Research Centre	Bhopal
India	SEAROC Cancer Center, S. K. Soni hospital	Jaipur
India	Shatabdi Super Specialty Hospital	Mumbai
India	Cancer Clinic, Shreevardhan complex	Nagpur
India	Mahavir Cancer Sansthan	Phulwarisharif	Patna
India	Ruby Hall Clinic	Pune
Italy	Azienda Ospedaliero-Universitaria Riunti	Ancona
Italy	Azienda Ospedaliera Careggi U.O. Oncologia Medica	Firenze
Italy	Azienda Ospedaliera Universitaria Padovana	Padova
Italy	Policlinico Tor Vergata - Oncologia Medica	Rome
Latvia	Riga Eastern Hospital, Latvian Oncology Center	Riga
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej -Curie Oddzial w Krakowie	Kraków
Poland	Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej	Kraków
Poland	Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej	Lódz
Poland	Klinika Chirurgii Onkologicznej	Lublin
Poland	Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii	Olsztyn
Poland	Klinika Chirurgii Ogólnej i Onkologicznej	Szczecin
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej -Curie, Klinika Nowotworów Jelita Grubego	Warszawa
Romania	Fundeni Clinical Institute	Bucharest
Romania	Oncology Institute "Ion Chircuta"	Cluj-Napoca
Romania	St. Spiridon University Emergency Hospital	Iasi
Russian Federation	State Institution "Altay" Territorial Oncological Dispensary	Barmaul
Russian Federation	State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"	Ekaterinburg
Russian Federation	Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation	Moscow
Russian Federation	Municipal Cliical Hospital # 33 named after Ostroumov	Moscow
Russian Federation	Russian Oncological Scientific Center named after Blokhin	Moscow
Russian Federation	Privolzhsky District Medical Center	Nizhny Novgorod
Russian Federation	Central Research Institute of Roentgenology and Radiology	St. Petersburg
Russian Federation	Scientific Research Institution of Oncology	St. Petersburg
Russian Federation	State Educational Institution of High Professional Education "Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia"	St. Petersburg
Russian Federation	Tambov Regional Oncological Dispensary	Tambov
Russian Federation	State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"	Yaroslavl
Serbia	Institute of Oncology and Radiology of Serbia	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	Institute of Oncology	Sremska Kamenica
Sweden	Karolinska University Hospital	Stockholm
Ukraine	Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy	Cherkassy
Ukraine	Municipal Multiple-Discipline Clinical Hospital #4	Dnepropetrovsk
Ukraine	Donetsk Cancer Centre	Donetsk
Ukraine	Kharkov Regional Clinical Oncology Dispansery	Kharkov
Ukraine	The Central Hospital of the Ministry of Defense	Kyiv
Ukraine	Zaporozhye Medical Academy for postgraduate education	Zaporozhye

Sponsors (1)

Lead Sponsor	Collaborator
Light Sciences Oncology

Countries where clinical trial is conducted

Austria,  Bosnia and Herzegovina,  Croatia,  Germany,  India,  Italy,  Latvia,  Poland,  Romania,  Russian Federation,  Serbia,  Sweden,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time from randomization to death	Up to 184 weeks	No