Clinical trial NCT00813696: Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer
Official title: Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: chemotherapy
advanced cancer
inoperable
Stage II, III, IV
Lead sponsor: Istituti Tumori Giovanni Paolo II
Sponsor class: NETWORK
Collaborators: name: Gruppo Oncologico Italia Meridionale
name: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
name: Gruppo Oncologico Italiano di Ricerca Clinica
name: Cattedra di Endocrinochirurgia, Università di Verona
First posted: 2008-12-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis pancreatic cancer
* inoperable stage II or stage III or IV disease(UICC, 1997)
* Age 18 to 75 years
* Karnofsky Performance status \> 50
* Signed informed consent

Exclusion Criteria:

* Previous chemotherapy
* Cerebral metastases
* Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
* Leukocytes \< 4000 or neutrophils \< 2000 or platelets \< 100000 or hemoglobin \< 10 g/dl
* Creatinine value \> upper normal limit
* GOT or GPT \> 2.5 times upper normal limit or bilirubin \> 1.5 times upper normal limit in absence of hepatic metastases
* Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
* Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
* Inability to provide informed consent
* Inability to comply with follow-up.

Primary outcomes:
measure: overall survival
timeFrame: 9 months
Secondary outcomes:
measure: clinical benefit response
timeFrame: baseline and at end of every cycle of therapy
measure: quality of life
timeFrame: baseline and at end of every cycle of therapy
measure: objective response
timeFrame: after 7 weeks of therapy
measure: time to progression
timeFrame: 6 months
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Ospedal Miulli
city: Ancona
country: Italy
facility: Ospedale Regionale Torrette
city: ARco
country: Italy
facility: Presidio Osp. Alto Garda e Ledro
city: Aviano
country: Italy
facility: Centro Riferimento Oncologico
city: Bari
country: Italy
facility: Istituto Oncologico Giovanni Paolo II
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli
city: Bergamo
country: Italy
facility: Ospedale Riuniti
city: Biella
country: Italy
facility: Ospedale degli Infermi
city: Bolzano
country: Italy
facility: Ospedale Regionale
city: Cagliari
country: Italy
facility: Policlinico Universitario
city: Campobasso
country: Italy
facility: Ospedale A. Cardarelli
city: Carpi
country: Italy
facility: Ospedale Ramazzini
city: Catania
country: Italy
facility: Centro Catanese di Oncologia
city: Chieti
country: Italy
facility: Università di Chieti "D'Annunzio"
city: Como
country: Italy
facility: Ospedale Valduce
city: Fano
country: Italy
facility: Ospedale Santa Croce
city: Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria
city: Firenze
country: Italy
facility: Azienda Ospedale Careggi
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi
city: Lugo
country: Italy
facility: Ospedale Umberto I
city: Manerbio
country: Italy
facility: Pres. Osp. di Manerbio
city: Milano
country: Italy
facility: Ospedale L. Sacco
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Monteforte Irpino
country: Italy
facility: Ospedale G. Moscati
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Olbia
country: Italy
facility: Ospedale Civile
city: Palermo
country: Italy
facility: Casa di Cura La Maddalena
city: Palermo
country: Italy
facility: Policlinico Giaccone
city: Pesaro
country: Italy
facility: Ospedale San Salvatore-Muraglia
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Potenza
country: Italy
facility: Ospedale San Carlo
city: Roma
country: Italy
facility: Azienda Policlinico S. Andrea
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli
city: Roma
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Policlinico Militare Celio
city: Roma
country: Italy
facility: Polo Oncologico Istituto Regina Elena
city: Rovereto
country: Italy
facility: Ospedale Civile
city: Rovigo
country: Italy
facility: Ospedale Civile
city: S. Vito al Tagliamento
country: Italy
facility: Centro Oncologico
city: Trento
country: Italy
facility: Ospedale Santa Chiara
city: Treviglio
country: Italy
facility: Azienda Ospedaliera Treviglio-Caravaggio
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
Study officials:
affiliation: Istituto Tumori Giovanni Paolo II
name: Giuseppe Colucci, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Riuniti Bergamo
name: Roberto Labianca, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Careggi
name: Francesco Di Costanzo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Riuniti Umberto I-Lancise-Salese
name: Stefano Cascinu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico G.B. Rossi, Verona
name: Paolo Pederzoli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colucci G, Labianca R, Di Costanzo F, Gebbia V, Carteni G, Massidda B, Dapretto E, Manzione L, Piazza E, Sannicolo M, Ciaparrone M, Cavanna L, Giuliani F, Maiello E, Testa A, Pederzoli P, Falconi M, Gallo C, Di Maio M, Perrone F; Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 2010 Apr 1;28(10):1645-51. doi: 10.1200/JCO.2009.25.4433. Epub 2010 Mar 1.