Clinical trial NCT00674973: A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer
Official title: A Phase II Biomarker Identification Trial for Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
* measurable disease according to RECIST;
* failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
* ECOG performance status of 0-2.

Exclusion Criteria:

* local or locally advanced-resectable pancreatic cancer;
* any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
* major surgery within 2 weeks prior to randomization.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From the time of randomization until progression of disease or death (up to 30 months)
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response Rate
timeFrame: From the time of randomization until progression of disease or death (up to 30 months)
measure: Percentage of Participants With Disease Control Rate (DCR)
timeFrame: Randomization to Clinical Cutoff: 20 December 2010 (up to 30 months)
measure: Overall Survival
timeFrame: From the time of randomization until or death (up to 30 months)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 28 days after discontinuation of study drug (up to 30 months)
Other outcomes:
Locations:
city: Kogarah
country: Australia
state: New South Wales
city: St. Leonards
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Box Hill
country: Australia
state: Victoria
city: Salvador, Bahia
country: Brazil
state: BA
city: Belo Horizonte
country: Brazil
state: MG
city: Curitiba
country: Brazil
state: PR
city: Ijui
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Jau
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Gabrovo
country: Bulgaria
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Vratza
country: Bulgaria
city: Zagreb
country: Croatia
city: Bochum
country: Germany
city: Dresden
country: Germany
city: Esslingen
country: Germany
city: Greifswald
country: Germany
city: Hamburg
country: Germany
city: Köln
country: Germany
city: Saarbruecken
country: Germany
city: Ulm
country: Germany
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Bangalore
country: India
city: Chennai
country: India
city: Jaipur
country: India
city: Kochi
country: India
city: Kolkata
country: India
city: Ludhiana
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Vellore
country: India
city: Bologna
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Kuala Lumpur
country: Malaysia
city: Penang
country: Malaysia
city: Monterrey
country: Mexico
city: Arequipa
country: Peru
city: Chiclayo
country: Peru
city: San Isidro
country: Peru
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Craiova (Dolj county)
country: Romania
city: Irkutsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Singapore
country: Singapore
city: Ljubljana
country: Slovenia
city: Kiev
country: Ukraine
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Propper D, Davidenko I, Bridgewater J, Kupcinskas L, Fittipaldo A, Hillenbach C, Klughammer B, Ducreux M. Phase II, randomized, biomarker identification trial (MARK) for erlotinib in patients with advanced pancreatic carcinoma. Ann Oncol. 2014 Jul;25(7):1384-1390. doi: 10.1093/annonc/mdu176. Epub 2014 May 14.