Clinical trial NCT00550004: Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
Official title: Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Unresectable
locally advanced
metastatic pancreatic adenocarcinoma
Stage III
Stage IV
Lead sponsor: SciClone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-10-26
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).


Eligibility criteria: Inclusion Criteria:

* Subjects must be 18 years of age or older
* Not previously treated with chemotherapy for Pancreatic Cancer
* ECOG performance status of 0 or 1
* Life expectancy \> 3 months
* Documentation of all sites of pancreatic disease within 28 days prior to randomization
* Adequate hematological, renal, and hepatic function
* Not pregnant or nursing
* Fertile subjects must practice a medically approved method of contraception

Exclusion Criteria:

* Prior history of other malignant tumors
* Participation in another investigational study within 4 weeks prior to treatment start
* Major surgery within 14 days prior to treatment start
* Radiation treatment within 28 days prior to treatment start
* Uncontrolled cardiac atrial or ventricular arrhythmias
* Gastrointestinal tract disease such resulting in an inability to take oral medication
* Known to be seropositive for HIV, HBV, or HCV
* Uncontrolled cancer pain

Primary outcomes:
measure: Overall Survival
timeFrame: 18 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 14 months
measure: Evaluate the CA 19-9 levels
timeFrame: 12 months
measure: Compare changes in ECOG
timeFrame: 12 months
measure: Evaluate Safety of RP101
timeFrame: 18 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center, Arizona Cancer Center
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Research Foundation at Tower Oncology
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network, LLC
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Bismarck
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology, PA
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center
state: Wisconsin
city: Bahía Blanca
country: Argentina
facility: Hospital Italiano Regional del Sur
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Zonal General de Agudos San Roque
state: Buenos Aires
city: Ijuí
country: Brazil
facility: Hospital de Caridade de Ijuí
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre, Serviço de Oncologia
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Câncer
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
city: São Paulo
country: Brazil
facility: Hospital do Câncer-AC Camargo
city: Santiago de Chile
country: Chile
facility: Hospital Militar
city: Santiago
country: Chile
facility: Fundación Arturo López Pérez
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: La Roche sur Yon Cedex 9
country: France
facility: Centre Hospitalier Départemental
city: Rennes
country: France
facility: Centre Eugene Marquis, Service d'Oncologie Medicale
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, Med. Klinik I
city: Hannover
country: Germany
facility: Klinikum Region Hannover GmbH, Krankenhause Siloah
city: München
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
city: Gyor
country: Hungary
facility: Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia
state: Budapest
city: Budapest
country: Hungary
facility: Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet
city: Budapest
country: Hungary
facility: Fovárosi Önkormányzat Uzsoki utcai Kórháza
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék
city: Sittard
country: Netherlands
facility: Maaslandziekenhuis
city: La Victoria
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: San Borja
country: Peru
facility: Instituto Oncocenter
city: Jelenia Góra
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki
city: Kraków
country: Poland
facility: I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej
city: Lódz
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi
city: Rzeszów
country: Poland
facility: Centrum Medyczne MRUKMED
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Institutul Oncologic 'Prof. Dr. A. Trestioreanu'
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Floreasca
city: Bucuresti
country: Romania
facility: Spitalul Clinic Universitar de Urgenta
city: Lérida
country: Spain
facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
state: England
city: Middlesex
country: United Kingdom
facility: Mount Vernon Hospital
state: England
Study officials:
affiliation: Centro Integral de Oncologia
name: Manuel Hidalgo, MD, PhD
role: STUDY_CHAIR
References:
citation: Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.