Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced SCCHN Who Have Received at Least One Anti-cancer Treatment Regimen for Advanced Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00412776
• Other study ID #: VB4-845-01-IIIA
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: December 14, 2006
• Last updated: December 22, 2015
• Start date: December 2005
• Est. completion date: April 2008

Study information

• Verified date: December 2015
• Source: Viventia Bio
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyIsrael: Ministry of HealthMexico: Federal Commission for Sanitary Risks ProtectionRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Ministry of HealthGermany: Paul-Ehrlich-InstitutIndia: Ministry of HealthItaly: Ministry of HealthHungary: National Institute of PharmacyRomania: National Medicines AgencyCroatia: Ministry of Health and Social CareSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer.

Description:

Head and neck cancer is a general description of a disease that includes several types of soft tissue carcinomas that develop in the head and neck regions.

Proxinium is a recombinant fusion protein that binds to the epithelial cell adhesion molecule (Ep-CAM) that is highly expressed on squamous cell carcinomas of the head and neck (SCCHN). Proxinium is administered via intratumoural injection.

The primary objective of the study is to compare the overall survival time for patients treated with intratumourally injected Proxinium plus BSC versus BSC alone. Secondary objectives of the study include comparison of locoregional tumour control, local progression-free survival, symptomatic benefit and safety profile in patients who receive Proxinium plus BSC versus patients who receive BSC

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 165
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Disease Characteristics

• The patient must be 18 years of age or older.

• The patient must have squamous cell carcinoma of the head and neck.

• The squamous cell carcinoma must be Ep-CAM positive.

• ECOG performance status of 0, 1, 2 or 3.

• 12 week life expectancy

Prior/Concurrent Therapy

• The patient must have received therapy for their primary disease (eg, surgery and/or radiotherapy, chemo-radiotherapy or chemotherapy).

• The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour.

• The patient's disease must be refractory.

• There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug.

Patient Characteristics

• The patient must have adequate hepatic function [alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × upper limit of normal (ULN) and bilirubin level =1.5 × ULN].

• The patient must have adequate renal function (serum creatinine < 1.5 × ULN).

• The patient must have the following hematological values: granulocytes =1500/µL, platelets =75 000/µL and hemoglobin >8 g/dL.

• The patient must have prothrombin time and partial thromboplastin time within normal limits.

Other

• Women of childbearing potential and male patients must agree to use a highly effective contraceptive method.

Exclusion Criteria:

• The patient has clinically significant distant metastases.

• The patient is eligible to have surgical resection or radiotherapy, chemo-radiotherapy or chemotherapy.

• The patient has a nasopharyngeal tumour.

• The patient has AIDS, hepatitis C or hepatitis B.

• The patient has clinically significant renal or hepatic disease.

• Tumors are prone to bleeding.

• The patient is pregnant or lactating.

• The patient requires 'blood thinning' medications and can not safely discontinue the medication.

• The patient is currently enrolled in another clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Cancer
• Head and Neck Neoplasms
• Mouth Neoplasms
• Neoplasms
• Neoplasms, Squamous Cell

Intervention

Drug:
• Proxinium
700 µg Proxinium, once weekly until complete resolution of all target tumours or radiographic tumour progression

Locations

Country	Name	City	State
Argentina	Hospital Italiano Regional del Sur	Bahia Blanca
Argentina	Hospital Municipal de Agudos Leonidas Lucero	Bahia Blanca
Argentina	Centro de Estudio y Tratamiento de las Enfermedades Neoplasicas (CETEN)	Buenos Aires
Argentina	Hospital de Clinicas "Jose de San Martin"	Buenos Aires
Argentina	Hospital Nacional Alejandro Posadas	Buenos Aires
Argentina	Hospital Universitario Austral	Buenos Aires
Argentina	Instituto Medico Platense	La Plata
Argentina	Hospital Italiano Garibaldi	Rosario
Brazil	Hospital de Câncer de Barretos - Fundação Pio XII	Barretos
Brazil	Cettro - Centro de Tratamento Oncológico Ltda.	Brasilia
Brazil	Centro Regional Integrado de Oncologia - CRIO	Fortaleza
Brazil	Hospital Araújo Jorge	Goiania - GO
Brazil	Hospital Amaral Carvalho	Jau
Brazil	Pro-Onco Centro De Tratamento Oncológico S/C Ltda	Londrina
Brazil	Biocor - Hospital de Doenças Cardiovasculares Ltda	Nova Lima
Brazil	CECAN - Centro do Câncer Francisco Cunha Filho	Piracicaba
Brazil	Hospital São Lucas da PUCRS	Porto Alegre - RS
Brazil	Irmandade Santa Casa de Misericórdia de Porto Alegre	Porto Alegre - RS
Brazil	Instituto Ribeirãopretano de Combate ao Câncer	Riberao Preto-SP
Brazil	INCA - Instituto Nacional do Câncer	Rio de Janeiro
Brazil	SOS Vida - Soluções em Saúde	Salvador - BA
Brazil	Santo André Diagnósticos e Tratamentos Ltda	Santo Andre-SP
Brazil	Hospital Do Câncer A. C. Camargo	São Paulo
Brazil	Grupo de Pesquisas Médicas	São Paulo - SP
Brazil	Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo	São Paulo - SP
Croatia	Clinical Hospital "Sestre milosrdnice"	Zagreb
Croatia	Clinical Hospital Centre Zagreb, Clinic for ENT, Department for Head and Neck Surgery	Zagreb
Croatia	Universtity Hospital for Tumors, Department for Head and Neck Surgery	Zagreb
France	Centre Georges-Francois Leclerc	Dijon
France	Clinique Guillaume Le Conquerant	Le Havre
France	Centre Régional de Lutte contre le Cancer Val d'Aurelle	Montpellier
Germany	Charité -Universitätsmedizin Berlin	Berlin
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universität Heidelberg	Heidelberg
Germany	Universitätsklinikum Köln	Köln
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinikum Schleswig Holstein	Lübeck
Germany	Johannes Gutenberg-Universität	Mainz
Germany	Klinikum der Philipps-Universität Marburg	Marburg
Germany	Universitätsklinikum Tübingen	Tübingen
Hungary	Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Fej-nyaksebeszet	Budapest
Hungary	Orszagos Onkologiai Intezet	Budapest
Hungary	Debreceni Egyetem OEC, Onkologiai Tanszek	Debrecen
Hungary	Petz Aladar Megyei Korhaz, Ful-orr-gege, Fej, Nyak Sebeszet	Gyor
India	Department of Medical Oncology, Bangalore Institute of Oncology	Bangalore
India	Kidwai Memorial Institute of Oncology	Bangalore
India	Global Hospitals	Hyderabaad
India	MNJ Institute of Oncology	Hyderabaad
India	Nizam's Institute of Medical Sciences	Hyderabaad
India	Birla Cancer Institute SMS Medical College Hospital	Jaipur
India	SK Soni Hospital	Jaipur
India	Soumya Hospita	Karkhana
India	Amrita Institute of Medical Sciences and Research Centre	Kochin
India	Netaji Subash Chandra Bose Cancer Research Institute	Kolkata
India	Orchid Nursing Home	Kolkata
India	Department of Medical Oncology Dayanand Medical College & Hospital	Ludhiana
India	Asian Institute of Oncology, S L Raheja Hospital	Mumbai
India	Tata Memorial Hospital	Mumbai
India	Department of Medical Oncology AIIMS, Institute Rotary Cancer Hospital	New Delhi
India	Department of Medical Oncology Rajiv Gandhi Cancer Institute and Research Centre	New Delhi
India	Regional Cancer Centre	Trivandrum
Israel	Soroka University Medical Center	Beer Sheva
Israel	The Lady Davis Carmel Medical Center	Haifa
Israel	Haddasa Ein Carem Hospital	Jerusalem
Israel	Rabin Medical Center	Petach Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv University Medical School	Tel Aviv
Israel	Sheba - Medical Center	Tel-Hashomer
Italy	Azienda Ospedaliera San Gerardo	Monza
Italy	IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera Pisana	Pisa
Mexico	Hospital Clínica del Parque	Chihuahua, Chih.
Mexico	Centro Anticanceroso de la Cruz Roja Mexicana de Mérida	Merida
Mexico	OCA Hospital	Monterrey N.L.
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi, SLP
Mexico	Hospital "Dr. Angel Leaño"	Zapopan, Jalisco
Poland	Swietokrzyskie Centrum Onkologii	Kielce
Poland	Wojewodzki Szpital Specjalistyczny im. L.Rydygiera	Krakow
Poland	Wojewodzki Szpital Specjalistyczny im. Mikolaja Kopernika, Regionalny Osrodek Onkologiczny	Lodz
Poland	Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii	Olsztyn
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Opolskie Centrum Onkologii	Opole
Poland	Wielkopolskie Centrum Onkologii	Poznan
Poland	Centrum Onkologii Instytut im. M. Sklodowskiej-Curie	Warszawa
Romania	"Prof. Dr. I. Chiricuta" Institute of Oncology Medical Oncology and Radiotherapy II Department	Cluj-Napoca
Romania	Oradea Clinical County Hospital Department of Medical Oncology	Oradea
Russian Federation	Regional Oncology Dispensary	Astrakhan
Russian Federation	Sverdlovsk Regional Oncology Dispensary	Ekaterinburg
Russian Federation	State Medical Institution Kursk Regional Oncology Dispensary Out-patient department	Kursk
Russian Federation	Central Clinical Hospital #2 after MA Semashko OAO "RRW"	Moscow
Russian Federation	Moscow Scientific-Research Oncology Institute after P.A. Gertsen	Moscow
Russian Federation	SI Russian Oncology Scientific Center after NN Blokhin RAMS	Moscow
Russian Federation	PHI OAO RRW Railway Clinical Hospital at station Gorkiy	Nizhniy Novgorod
Russian Federation	Stavropol Regional Oncology Center, Pyatigorsk branch Out-patient department	Pyatigorsk
Russian Federation	PHI Dorozhnaya Clinical Hospital at Saratov II Station of Pryvolzhskaya railway OAO Russian Railways	Saratov
Russian Federation	SIH Leningrad Regional Oncology Dispansery	St. Petersburg
Russian Federation	SPBSIH City Clinical Oncology Dispensary	St. Petersburg
Russian Federation	Tambov Regional Oncological Dispensary Surgery Department	Tambov
Russian Federation	Republican Clinical Oncological Dispenser Radiological Therapy	Ufa
Russian Federation	State Medical Institution Regional Clinical Oncology Dispensary	Ulyanovsk
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	Military Medical Academy (MMA) Clinic for Maxillofacial Surgery	Belgrade
Slovakia	Teaching Hospital with Policlinic of F. D. Roosevelt Department of Otorhinolaryngology and Surgery	Banská Bystrica
Slovakia	Oncology Institute of St. Elisabeth Clinic of Stomatology and Maxillofacial Surgery	Bratislava
Slovakia	Teaching Hospital with Policlinic Bratislava 1st Clinic of Otorhinolaryngology	Bratislava
Slovakia	Vychodoslovensky oncologicky ustav a.s.	Kosice
Slovakia	Teaching Hospital with Policlinic Nové Zámky Clinic of Otorhinolaryngology	Nove Zamky
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Provincial de Pontevedra	Pontevedra
Spain	Hospital Universitario de Salamanca	Salamanca, Castilla y León
Ukraine	Chernovtsy Regional Oncology Center	Chernivtsy
Ukraine	Kharkov Regional Clinical Oncology Dispensary	Kharkov
Ukraine	Institute of Oncology of AMS of Ukraine	Kiev
Ukraine	Institute of Otolaryngology	Kiev
Ukraine	Volyn Regional Oncology Dispensary	Lutsk
Ukraine	Uzhgorod National University	Uzhorod
Ukraine	Zaporozhye Regional Clinical Oncology Dispensary	Zaporozhye
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Christie Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Viventia Bio

Countries where clinical trial is conducted

Argentina,  Brazil,  Croatia,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Death or 12 months from the date that the last patient required for efficacy analysis has been randomized	No
Secondary	Tumour response, safety and quality of life		Death or 12 months from the date that the last patient required for efficacy analysis has been randomized	No