Clinical trial NCT00440310: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Metastases
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasm Recurrence, Local
Keywords: Liver neoplasms
Liver metastases
MCRC
Litx™
LS11
Colorectal cancer with recurrent liver metastases
Lead sponsor: Light Sciences Oncology
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 184 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Wien
country: Austria
facility: Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel
city: Mostar
country: Bosnia and Herzegovina
facility: Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Centre of the University of Sarajevo, Institute of Oncology
city: Karlovac
country: Croatia
facility: General Hospital Karlovac
city: Zagreb
country: Croatia
facility: Clinical Centre Zagreb, Clinical Oncology
city: Zagreb
country: Croatia
facility: General Hospital "Sveti Duh"
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Aalen
country: Germany
facility: Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I
city: Borna
country: Germany
facility: Helios Kliniken - Innere Medizin und Kardiologie
city: Erfurt
country: Germany
facility: Katholisches Krankenhaus St. Johann Nepomuk
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe Universitat
city: Ludwigsburg
country: Germany
facility: Kliniken Ludwigsburg Bietigheim
city: Bangalore
country: India
facility: Bangalore Institute of Oncology
state: Karnataka
city: Phulwarisharif
country: India
facility: Mahavir Cancer Sansthan
state: Patna
city: Aurangabad
country: India
facility: CIIGMA Institute of Medical Sciences
city: Bhopal
country: India
facility: Jawaharlal Nehru Cancer Hospital and Research Centre
city: Jaipur
country: India
facility: SEAROC Cancer Center, S. K. Soni hospital
city: Mumbai
country: India
facility: Shatabdi Super Specialty Hospital
city: Nagpur
country: India
facility: Cancer Clinic, Shreevardhan complex
city: Pune
country: India
facility: Ruby Hall Clinic
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Riunti
city: Firenze
country: Italy
facility: Azienda Ospedaliera Careggi U.O. Oncologia Medica
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria Padovana
city: Rome
country: Italy
facility: Policlinico Tor Vergata - Oncologia Medica
city: Riga
country: Latvia
facility: Riga Eastern Hospital, Latvian Oncology Center
city: Kraków
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie
city: Kraków
country: Poland
facility: Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej
city: Lublin
country: Poland
facility: Klinika Chirurgii Onkologicznej
city: Olsztyn
country: Poland
facility: Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii
city: Szczecin
country: Poland
facility: Klinika Chirurgii Ogólnej i Onkologicznej
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego
city: Łódź
country: Poland
facility: Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Cluj-Napoca
country: Romania
facility: Oncology Institute "Ion Chircuta"
city: Iasi
country: Romania
facility: St. Spiridon University Emergency Hospital
city: Barmaul
country: Russian Federation
facility: State Institution "Altay" Territorial Oncological Dispensary
city: Ekaterinburg
country: Russian Federation
facility: State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation
city: Moscow
country: Russian Federation
facility: Municipal Cliical Hospital # 33 named after Ostroumov
city: Moscow
country: Russian Federation
facility: Russian Oncological Scientific Center named after Blokhin
city: Nizhny Novgorod
country: Russian Federation
facility: Privolzhsky District Medical Center
city: St. Petersburg
country: Russian Federation
facility: Central Research Institute of Roentgenology and Radiology
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Institution of Oncology
city: St. Petersburg
country: Russian Federation
facility: State Educational Institution of High Professional Education "Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia"
city: Tambov
country: Russian Federation
facility: Tambov Regional Oncological Dispensary
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Sremska Kamenica
country: Serbia
facility: Institute of Oncology
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Cherkassy
country: Ukraine
facility: Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy
city: Dnepropetrovsk
country: Ukraine
facility: Municipal Multiple-Discipline Clinical Hospital #4
city: Donetsk
country: Ukraine
facility: Donetsk Cancer Centre
city: Kharkov
country: Ukraine
facility: Kharkov Regional Clinical Oncology Dispansery
city: Kyiv
country: Ukraine
facility: The Central Hospital of the Ministry of Defense
city: Zaporozhye
country: Ukraine
facility: Zaporozhye Medical Academy for postgraduate education
Study officials:
affiliation: Light Sciences Oncology
name: Sy-Shi Wang, PhD
role: STUDY_DIRECTOR
References: