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

Phase 3

Completed

• Conditions: Liver Metastases; Neoplasm Metastasis; Colorectal Neoplasms; Neoplasm Recurrence, Local
• Interventions: Drug: Talaporfin sodium; Drug: FOLFOX4 regimen; Procedure: Percutaneous placement of device in liver metastases; Device: Interstitial light emitting diodes; Drug: FOLFIRI regimen

• Registration Number: NCT00440310
• Lead Sponsor: Light Sciences Oncology

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).

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-23
• Study First Posted: 2007-02-27
• Primary Completion: 2011-05
• Study Completion: 2011-10
• Disposition First Submitted: 2015-01-09
• Disposition First Submitted QC: 2015-01-09
• Disposition First Posted: 2015-01-22
• Status Verified: 2015-07
• Results First Submitted: 2015-07-28
• Results First Submitted QC: 2015-07-28
• Last Update Submitted: 2015-07-28
• Results First Posted: 2015-08-25
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Litx + Chemotherapy	Talaporfin sodium	-
Litx + Chemotherapy	FOLFIRI regimen	-
Chemotherapy alone	FOLFOX4 regimen	-
Litx + Chemotherapy	FOLFOX4 regimen	-
Chemotherapy alone	FOLFIRI regimen	-
Litx + Chemotherapy	Percutaneous placement of device in liver metastases	-
Litx + Chemotherapy	Interstitial light emitting diodes	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 184 weeks	Time from randomization to death

Trial Locations

Locations (57)

Clinical Centre of the University of Sarajevo, Institute of Oncology; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Clinical Centre Zagreb, Clinical Oncology; 🇭🇷 Zagreb, Croatia

Katholisches Krankenhaus St. Johann Nepomuk; 🇩🇪 Erfurt, Germany

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Austria

Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology; 🇧🇦 Mostar, Bosnia and Herzegovina

Ostalb-Klinikum Aalen Darmzentrum Medizinische Klinik I; 🇩🇪 Aalen, Germany

Helios Kliniken - Innere Medizin und Kardiologie; 🇩🇪 Borna, Germany

SEAROC Cancer Center, S. K. Soni hospital; 🇮🇳 Jaipur, India

Johann Wolfgang Goethe Universitat; 🇩🇪 Frankfurt, Germany

Mahavir Cancer Sansthan; 🇮🇳 Phulwarisharif, Patna, India

Klinika Chirurgii Ogólnej i Onkologicznej; 🇵🇱 Szczecin, Poland

Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej; 🇵🇱 Kraków, Poland

Institute of Oncology; 🇷🇸 Sremska Kamenica, Serbia

Kharkov Regional Clinical Oncology Dispansery; 🇺🇦 Kharkov, Ukraine

Krankenhaus Hietzing mit Neurologischen Zentrum Rosenhugel; 🇦🇹 Wien, Austria

General Hospital Karlovac; 🇭🇷 Karlovac, Croatia

General Hospital "Sveti Duh"; 🇭🇷 Zagreb, Croatia

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia

Kliniken Ludwigsburg Bietigheim; 🇩🇪 Ludwigsburg, Germany

Bangalore Institute of Oncology; 🇮🇳 Bangalore, Karnataka, India

Jawaharlal Nehru Cancer Hospital and Research Centre; 🇮🇳 Bhopal, India

Shatabdi Super Specialty Hospital; 🇮🇳 Mumbai, India

Cancer Clinic, Shreevardhan complex; 🇮🇳 Nagpur, India

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, Italy

Riga Eastern Hospital, Latvian Oncology Center; 🇱🇻 Riga, Latvia

Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie Oddział w Krakowie; 🇵🇱 Kraków, Poland

Centrum Onkologii - Instytut im. Marii Skłodowskiej -Curie, Klinika Nowotworów Jelita Grubego; 🇵🇱 Warszawa, Poland

State Healthcare Institution of Yaroslavl region, "Regional clinical oncological hospital"; 🇷🇺 Yaroslavl, Russian Federation

CIIGMA Institute of Medical Sciences; 🇮🇳 Aurangabad, India

Klinika Chirurgii Onkologicznej; 🇵🇱 Lublin, Poland

Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii; 🇵🇱 Olsztyn, Poland

Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej; 🇵🇱 Łódź, Poland

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania

State Healthcare Institution "Sverdlovsk' Regional Oncological Dispensary"; 🇷🇺 Ekaterinburg, Russian Federation

Privolzhsky District Medical Center; 🇷🇺 Nizhny Novgorod, Russian Federation

Main Military Clinical Hospital named after Burdenko attached to Ministry of Defense of Russian Federation; 🇷🇺 Moscow, Russian Federation

Oncology Institute "Ion Chircuta"; 🇷🇴 Cluj-Napoca, Romania

St. Spiridon University Emergency Hospital; 🇷🇴 Iasi, Romania

State Institution "Altay" Territorial Oncological Dispensary; 🇷🇺 Barmaul, Russian Federation

Municipal Cliical Hospital # 33 named after Ostroumov; 🇷🇺 Moscow, Russian Federation

Russian Oncological Scientific Center named after Blokhin; 🇷🇺 Moscow, 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

Institute of Oncology and Radiology of Serbia; 🇷🇸 Belgrade, Serbia

Military Medical Academy; 🇷🇸 Belgrade, Serbia

Donetsk Cancer Centre; 🇺🇦 Donetsk, Ukraine

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Municipal Institution "Cherkassy" Regional Oncological Dispensary of Cherkassy; 🇺🇦 Cherkassy, Ukraine

Municipal Multiple-Discipline Clinical Hospital #4; 🇺🇦 Dnepropetrovsk, Ukraine

Zaporozhye Medical Academy for postgraduate education; 🇺🇦 Zaporozhye, Ukraine

The Central Hospital of the Ministry of Defense; 🇺🇦 Kyiv, Ukraine

Ruby Hall Clinic; 🇮🇳 Pune, India