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Phase 3 Trial of Litx™ Plus Chemotherapy vs. Chemotherapy Only Treating Colorectal Cancer Patients With Recurrent Liver Metastases
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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LSO-OL006
NCT00440310
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Trial Description
Summary The purpose of the study is to assess the progression free survival and overall 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, Snoqualmie, 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. Further Study Information 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
- 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 bevacuzimab (Avastin®) or cetuximab (Erbitux®) within 30 days of randomization. Use of bevacuzimab 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Light Sciences Corporation | Sy-Shi Wang, PhD | | Study Director |
Trial Sites
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| Austria |
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Feldkirch |
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| | | | | | | | Landeskrankenhaus Feldkirch |
| | | Alois Lang, MD | |
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Email:
alois.lang@lkhf.at |
| | | Alois Lang, MD | Principal Investigator |
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| Bosnia and Herzegovina |
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Mostar |
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| | | | Clinical Hospital Mostar, Internal Clinic, Department of Gastroenterology |
| | | Milenko Bevanda, D.Sci | |
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Email:
daniela.bevanda@tel.net.ba |
| | | Milenko Bevanda, D.Sci | Principal Investigator |
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Sarajevo |
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| | | Clinical Centre of the University of Sarajevo, Institute of Oncology |
| | | Semir Bešlija, MD | |
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Email:
onkokcus@bih.net.ba |
| | | Semir Bešlija, MD | Principal Investigator |
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| Croatia |
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Rijeka |
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| | | | Clinical Centre Rijeka, Department of Internal Medicine |
| | | Davor Štimac, M.D., Ph.D | |
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Email:
Interna-rijeka@kbc-rijeka.hr |
| | | Davor Štimac, MD, PhD | Principal Investigator |
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Zagreb |
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| | | Clinical Centre Zagreb, Clinical Oncology |
| | | Zdenko Krajina, MD | |
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Email:
zdenko.krajina@gmail.com |
| | | Zdenko Krajina, MD | Principal Investigator |
| | | Klinicka Bolnica Dubrava |
| | | Zeljko Cabrijan, MD | |
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Email:
zeljko.cabrijan@zg.t-com.hr |
| | | Milan Kujundži, MD, PhD | Principal Investigator |
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| Germany |
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Frankfurt |
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| | | | Johann Wolfgang Goethe Universitat |
| | | Thomas Vogl, MD | |
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Email:
t.vogl@em.uni-frankfurt.de |
| | | Thomas Vogl, MD | Principal Investigator |
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Halle |
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| | | Martin-Luther-Universität Halle-Wittenberg |
| | | Dirk Arnold, MD | |
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Email:
dirk.arnold@medizin.uni-halle.de |
| | | Dirk Arnold, MD | Principal Investigator |
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| Italy |
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Ancona |
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| | | | Azienda Ospedaliero-Universitaria Riunti |
| | | Stefano Cascinu, MD | |
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Email:
s.cascinu@ao-umbertoprimo.marche.it |
| | | Stefano Cascinu | Principal Investigator |
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| Latvia |
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Riga |
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| | | | Riga Eastern Hospital, Latvian Oncology Center |
| | | Krumins Viesturs, MD | |
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Email:
viesturs@onkoc.mt.lv |
| | | Krumins Viesturs, MD | Principal Investigator |
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| Poland |
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Kraków |
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| | | | Centrum Onkologii - Instytut im. Marii Sklodowskiej -Curie Oddzial w Krakowie |
| | | Janusz Rolski, MD | |
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Email:
cht-krak@wp.pl |
| | | Janusz Rolski, MD | Principal Investigator |
| | | Szpital Uniwersytecki CMUJ, Klinika Chirurgii Ogólnej i Gastroenterologicznej |
| | | Jan Kulig, MD | |
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Email:
mskulig@cyf-kr.edu.pl |
| | | Jan Kulig, MD | Principal Investigator |
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Lódz |
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| | | Szpital Wojewódzki im. M. Kopernika, Klinika Chemioterapii Onkologicznej |
| | | Anna Pluzanska, MD | |
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Email:
apluzanska@o2.pl |
| | | Anna Pluzanska, MD | Principal Investigator |
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Lublin |
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| | | Klinika Chirurgii Onkologicznej |
| | | Wojciech Polkowski, MD | |
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Email:
wojciech.polkowski@am.lublin.pl |
| | | Wojciech Polkowski, MD | Principal Investigator |
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Szczecin |
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| | | Klinika Chirurgii Ogólnej i Onkologicznej |
| | | Józef Kladny, MD | |
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Email:
jkladny@sci.pam.szczecin.pl |
| | | Józef Kladny, MD | Principal Investigator |
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Warszawa |
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| | | Centrum Onkologii - Instytut im. Marii Sklodowskiej -Curie, Klinika Nowotworów Jelita Grubego |
| | | Marek Nowacki, MD | |
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Email:
dyrektor@coi.waw.pl |
| | | Marek Nowacki, MD | Principal Investigator |
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| Romania |
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Bucharest |
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| | | | Institutul Clinic Fundeni |
| | | Irinel Popescu, MD | |
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Email:
irinel.popescu@icfundeni.ro |
| | | Irinel Popescu, MD | Principal Investigator |
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Iasi |
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| | | St. Spiridon University Emergency Hospital |
| | | Tarcoveanu Eugen, MD | |
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Email:
etarco@iasi.mednet.ro |
| | | Tarcoveanu Eugen, MD | Principal Investigator |
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Timisoara |
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| | | Oncology Institute "Ion Chircuta" Cluj-Napoca |
| | | Ciuleanu Tudor-Eliade, MD, PhD | |
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Email:
tudor@iocn.ro |
| | | Ciuleanu Tudor-Eliade, MD, PhD | Principal Investigator |
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| Serbia |
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Belgrade |
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| | | | Institute of Oncology and Radiology of Serbia |
| | | Dusanka Jelecanin | |
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Email:
jelecanind@ncrc.ac.yu |
| | | Ivan Popov, MD | Principal Investigator |
| | | Military Medical Academy |
| | | Radoje Doder, MD | |
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Email:
doder@eunet.yu |
| | | Radoje Doder, MD | Principal Investigator |
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Sremska Kamenica |
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| | | Institute of Oncology |
| | | Matejasev Stanka | |
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Email:
matejasev.stanka@onko.onk.ns.ac.yu |
| | | Dusan Jovanovic, MD, PhD | Principal Investigator |
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| Slovakia |
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Bratislava |
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| | | | St. Elizabeth Cancer Institute |
| | | Stanislav Špánik, MD | |
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Email:
sspanik@ousa.sk |
| | | Stanislav Špánik, MD | Principal Investigator |
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| Sweden |
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Stockholm |
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| | | | Karolinska University Hospital |
| | | Ake Andren-Sandberg, MD | |
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Email:
ake.andren-sandberg@karolinska.se |
| | | Ake Andren-Sandberg, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00440310
Information obtained from ClinicalTrials.gov on October 02, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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