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

NCT ID: NCT00440310

Last Updated: 2015-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 483 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2011-10-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Litx + Chemotherapy

Group Type: EXPERIMENTAL

Talaporfin sodium

Intervention Type: DRUG

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

Percutaneous placement of device in liver metastases

Intervention Type: 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.

Interstitial light emitting diodes

Intervention Type: DEVICE

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

FOLFOX4 regimen

Intervention Type: DRUG

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

FOLFIRI regimen

Intervention Type: DRUG

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

Chemotherapy alone

Group Type: ACTIVE_COMPARATOR

FOLFOX4 regimen

Intervention Type: DRUG

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

FOLFIRI regimen

Intervention Type: DRUG

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

Interventions

Talaporfin sodium

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

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Interstitial light emitting diodes

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

Intervention Type: DEVICE

FOLFOX4 regimen

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

Intervention Type: DRUG

FOLFIRI regimen

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Light Sciences Oncology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sy-Shi Wang, PhD

Role: STUDY_DIRECTOR

Light Sciences Oncology

Locations

Landeskrankenhaus Feldkirch

Feldkirch, , Austria

Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel

Vienna, , Austria

Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology

Mostar, , Bosnia and Herzegovina

Clinical Centre of the University of Sarajevo, Institute of Oncology

Sarajevo, , Bosnia and Herzegovina

General Hospital Karlovac

Karlovac, , Croatia

Clinical Centre Zagreb, Clinical Oncology

Zagreb, , Croatia

General Hospital "Sveti Duh"

Zagreb, , Croatia

University Hospital Dubrava

Zagreb, , Croatia

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, , Germany

Bangalore Institute of Oncology

Bangalore, Karnataka, India

Mahavir Cancer Sansthan

Phulwarisharif, Patna, India

CIIGMA Institute of Medical Sciences

Aurangabad, , 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

Ruby Hall Clinic

Pune, , India

Azienda Ospedaliero-Universitaria Riunti

Ancona, , Italy

Azienda Ospedaliera Careggi U.O. Oncologia Medica

Florence, , Italy

Azienda Ospedaliera Universitaria Padovana

Padua, , Italy

Policlinico Tor Vergata - Oncologia Medica

Rome, , Italy

Riga Eastern Hospital, Latvian Oncology Center

Riga, , Latvia

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

Krakow, , Poland

Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej

Krakow, , Poland

Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej

Lodz, , Poland

Klinika Chirurgii Onkologicznej

Lublin, , Poland

Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii

Olsztyn, , Poland

Klinika Chirurgii Ogólnej i Onkologicznej

Szczecin, , Poland

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

Warsaw, , Poland

Fundeni Clinical Institute

Bucharest, , Romania

Oncology Institute "Ion Chircuta"

Cluj-Napoca, , Romania

St. Spiridon University Emergency Hospital

Iași, , Romania

State Institution "Altay" Territorial Oncological Dispensary

Barmaul, , Russia

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

Moscow, , Russia

Municipal Cliical Hospital # 33 named after Ostroumov

Moscow, , Russia

Russian Oncological Scientific Center named after Blokhin

Moscow, , Russia

Privolzhsky District Medical Center

Nizhny Novgorod, , Russia

Central Research Institute of Roentgenology and Radiology

Saint Petersburg, , Russia

Scientific Research Institution of Oncology

Saint Petersburg, , Russia

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

Tambov Regional Oncological Dispensary

Tambov, , Russia

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

Yaroslavl, , Russia

State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"

Yekaterinburg, , Russia

Institute of Oncology and Radiology of Serbia

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Institute of Oncology

Kamenitz, , Serbia

Karolinska University Hospital

Stockholm, , Sweden

Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy

Cherkassy, , Ukraine

Municipal Multiple-Discipline Clinical Hospital #4

Dnipro, , Ukraine

Donetsk Cancer Centre

Donetsk, , Ukraine

Kharkov Regional Clinical Oncology Dispansery

Kharkiv, , Ukraine

The Central Hospital of the Ministry of Defense

Kyiv, , Ukraine

Zaporozhye Medical Academy for postgraduate education

Zaporizhzhya, , Ukraine

Countries

Austria; Bosnia and Herzegovina; Croatia; Germany; India; Italy; Latvia; Poland; Romania; Russia; Serbia; Sweden; Ukraine

Other Identifiers

LSO-OL006

Identifier Type: -

Identifier Source: org_study_id