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

NCT00440310 | Completed Phase 3 Results DMC

• 1 other identifier: LSO-OL006
• Study Type: interventional
• Target: 483
• Locations: 12 countries
• Sites: 56

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.

Conditions

Liver Metastases; Colorectal Neoplasms; Neoplasm Metastasis; Neoplasm Recurrence, Local

Keywords

Liver neoplasms; Liver metastases; MCRC; Litx™; LS11; Colorectal cancer with recurrent liver metastases

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from randomization to death

  Up to 184 weeks

Study Arms (2)

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

Interventions

Talaporfin sodium DRUG

LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).

Litx + Chemotherapy

Percutaneous placement of device in liver metastases PROCEDURE

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.

Litx + Chemotherapy

Interstitial light emitting diodes DEVICE

200 J/cm per Light Source at 20 mW/cm light energy

Litx + Chemotherapy

FOLFOX4 regimen DRUG

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

Chemotherapy alone; Litx + Chemotherapy

FOLFIRI regimen DRUG

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

Chemotherapy alone; Litx + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Light Sciences Oncology: lead

Study Sites (57)

Landeskrankenhaus Feldkirch

Feldkirch, Austria

Location

Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel

Vienna, Austria

Location

Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology

Mostar, Bosnia and Herzegovina

Location

Clinical Centre of the University of Sarajevo, Institute of Oncology

Sarajevo, Bosnia and Herzegovina

Location

General Hospital Karlovac

Karlovac, Croatia

Location

Clinical Centre Zagreb, Clinical Oncology

Zagreb, Croatia

Location

General Hospital "Sveti Duh"

Zagreb, Croatia

Location

University Hospital Dubrava

Zagreb, Croatia

Location

Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I

Aalen, Germany

Location

Helios Kliniken - Innere Medizin und Kardiologie

Borna, Germany

Location

Katholisches Krankenhaus St. Johann Nepomuk

Erfurt, Germany

Location

Johann Wolfgang Goethe Universitat

Frankfurt, Germany

Location

Kliniken Ludwigsburg Bietigheim

Ludwigsburg, Germany

Location

Bangalore Institute of Oncology

Bangalore, Karnataka, India

Location

Mahavir Cancer Sansthan

Phulwarisharif, Patna, India

Location

CIIGMA Institute of Medical Sciences

Aurangabad, India

Location

Jawaharlal Nehru Cancer Hospital and Research Centre

Bhopal, India

Location

SEAROC Cancer Center, S. K. Soni hospital

Jaipur, India

Location

Shatabdi Super Specialty Hospital

Mumbai, India

Location

Cancer Clinic, Shreevardhan complex

Nagpur, India

Location

Ruby Hall Clinic

Pune, India

Location

Azienda Ospedaliero-Universitaria Riunti

Ancona, Italy

Location

Azienda Ospedaliera Careggi U.O. Oncologia Medica

Florence, Italy

Location

Azienda Ospedaliera Universitaria Padovana

Padua, Italy

Location

Policlinico Tor Vergata - Oncologia Medica

Rome, Italy

Location

Riga Eastern Hospital, Latvian Oncology Center

Riga, Latvia

Location

Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie

Krakow, Poland

Location

Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej

Krakow, Poland

Location

Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej

Lodz, Poland

Location

Klinika Chirurgii Onkologicznej

Lublin, Poland

Location

Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii

Olsztyn, Poland

Location

Klinika Chirurgii Ogólnej i Onkologicznej

Szczecin, Poland

Location

Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego

Warsaw, Poland

Location

Fundeni Clinical Institute

Bucharest, Romania

Location

Oncology Institute "Ion Chircuta"

Cluj-Napoca, Romania

Location

St. Spiridon University Emergency Hospital

Iași, Romania

Location

State Institution "Altay" Territorial Oncological Dispensary

Barmaul, Russia

Location

Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation

Moscow, Russia

Location

Municipal Cliical Hospital # 33 named after Ostroumov

Moscow, Russia

Location

Russian Oncological Scientific Center named after Blokhin

Moscow, Russia

Location

Privolzhsky District Medical Center

Nizhny Novgorod, Russia

Location

Central Research Institute of Roentgenology and Radiology

Saint Petersburg, Russia

Location

Scientific Research Institution of Oncology

Saint Petersburg, Russia

Location

State Educational Institution of High Professional Education "Military-Medical Academy named after S.M. Kirov attached to Ministry of Defense of Russia"

Saint Petersburg, Russia

Location

Tambov Regional Oncological Dispensary

Tambov, Russia

Location

State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"

Yaroslavl, Russia

Location

State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"

Yekaterinburg, Russia

Location

Institute of Oncology and Radiology of Serbia

Belgrade, Serbia

Location

Military Medical Academy

Belgrade, Serbia

Location

Institute of Oncology

Kamenitz, Serbia

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy

Cherkassy, Ukraine

Location

Municipal Multiple-Discipline Clinical Hospital #4

Dnipro, Ukraine

Location

Donetsk Cancer Centre

Donetsk, Ukraine

Location

Kharkov Regional Clinical Oncology Dispansery

Kharkiv, Ukraine

Location

The Central Hospital of the Ministry of Defense

Kyiv, Ukraine

Location

Zaporozhye Medical Academy for postgraduate education

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Neoplasm Recurrence, Local; Liver Neoplasms

Interventions

Talaporfin; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases

Results Point of Contact

• Title: Vice President of Regulatory Affairs and Clinical Operations
• Organization: Light Sciences Oncology, Inc.

lisak@lsoncology.com

425-957-8986

Study Officials

• Sy-Shi Wang, PhD

  Light Sciences Oncology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 27, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 25, 2015
• Results First Posted: August 25, 2015

Record last verified: 2015-07

Locations

PL (7); IN (8); IT (4); SE (3); RO (3); AU (2); BO (2); RU (11); UA (6); DE (5); CR (4); LA (1)