Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer
NCT ID: NCT00813696
Last Updated: 2008-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2002-04-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
cisplatin + gemcitabine
gemcitabine
1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks
cisplatin
25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
B
gemcitabine
gemcitabine
1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks
Interventions
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gemcitabine
1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks
cisplatin
25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Gruppo Oncologico Italia Meridionale
OTHER
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
OTHER
Gruppo Oncologico Italiano di Ricerca Clinica
OTHER
Cattedra di Endocrinochirurgia, Università di Verona
UNKNOWN
Istituti Tumori Giovanni Paolo II
NETWORK
Responsible Party
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GOIM
Principal Investigators
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Giuseppe Colucci, M.D.
Role: PRINCIPAL_INVESTIGATOR
Istituto Tumori Giovanni Paolo II
Roberto Labianca, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Riuniti Bergamo
Francesco Di Costanzo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Careggi
Stefano Cascinu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Riuniti Umberto I-Lancise-Salese
Paolo Pederzoli, M.D.
Role: PRINCIPAL_INVESTIGATOR
Policlinico G.B. Rossi, Verona
Ciro Gallo, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Locations
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Ospedal Miulli
Acquaviva delle Fonti, , Italy
Ospedale Regionale Torrette
Ancona, , Italy
Presidio Osp. Alto Garda e Ledro
Arco, , Italy
Centro Riferimento Oncologico
Aviano, , Italy
Istituto Oncologico Giovanni Paolo II
Bari, , Italy
Azienda Ospedaliera G. Rummo
Benevento, , Italy
Ospedale Fatebenefratelli
Benevento, , Italy
Ospedale Riuniti
Bergamo, , Italy
Ospedale degli Infermi
Biella, , Italy
Ospedale Regionale
Bolzano, , Italy
Policlinico Universitario
Cagliari, , Italy
Ospedale A. Cardarelli
Campobasso, , Italy
Ospedale Ramazzini
Carpi, , Italy
Centro Catanese di Oncologia
Catania, , Italy
Università di Chieti "D'Annunzio"
Chieti, , Italy
Ospedale Valduce
Como, , Italy
Ospedale Santa Croce
Fano, , Italy
Azienda Ospedaliera Universitaria
Ferrara, , Italy
Azienda Ospedale Careggi
Florence, , Italy
Azienda Ospedaliera Vito Fazzi
Lecce, , Italy
Ospedale Umberto I
Lugo, , Italy
Pres. Osp. di Manerbio
Manerbio, , Italy
Ospedale L. Sacco
Milan, , Italy
Ospedale San Paolo
Milan, , Italy
Ospedale G. Moscati
Monteforte Irpino, , Italy
Ospedale San Gerardo
Monza, , Italy
Istituto Nazionale Tumori
Napoli, , Italy
Ospedale Cardarelli
Napoli, , Italy
Ospedale Civile
Olbia, , Italy
Casa di Cura La Maddalena
Palermo, , Italy
Policlinico Giaccone
Palermo, , Italy
Ospedale San Salvatore-Muraglia
Pesaro, , Italy
Ospedale Guglielmo da Saliceto
Piacenza, , Italy
Ospedale San Carlo
Potenza, , Italy
Azienda Policlinico S. Andrea
Roma, , Italy
Ospedale Fatebenefratelli
Roma, , Italy
Ospedale San Raffaele
Roma, , Italy
Policlinico Militare Celio
Roma, , Italy
Polo Oncologico Istituto Regina Elena
Roma, , Italy
Ospedale Civile
Rovereto, , Italy
Ospedale Civile
Rovigo, , Italy
Centro Oncologico
S. Vito Al Tagliamento, , Italy
Ospedale Santa Chiara
Trento, , Italy
Azienda Ospedaliera Treviglio-Caravaggio
Treviglio, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Countries
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References
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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.
Other Identifiers
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GIP-1
Identifier Type: -
Identifier Source: org_study_id