Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer

NCT00813696 | Unknown Phase 3

• 1 other identifier: GIP-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 45

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.

Conditions

Pancreatic Cancer

Keywords

chemotherapy; advanced cancer; inoperable; Stage II, III, IV

Outcome Measures

Primary Outcomes (1)

• overall survival

  9 months

Secondary Outcomes (4)

• clinical benefit response

  baseline and at end of every cycle of therapy

• quality of life

  baseline and at end of every cycle of therapy

• objective response

  after 7 weeks of therapy

• time to progression

  6 months

Study Arms (2)

A

EXPERIMENTAL

cisplatin + gemcitabine

Drug: gemcitabine; Drug: cisplatin

B

ACTIVE COMPARATOR

gemcitabine

Drug: gemcitabine

Interventions

gemcitabine DRUG

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

A; B

cisplatin DRUG

25 mg/m2 IV on days 1, 8, and 15 every 4 weeks

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Tumori Giovanni Paolo II: lead
• Gruppo Oncologico Italia Meridionale: collaborator
• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: collaborator
• Gruppo Oncologico Italiano di Ricerca Clinica: collaborator
• Cattedra di Endocrinochirurgia, Università di Verona: collaborator

Study Sites (45)

Ospedal Miulli

Acquaviva delle Fonti, Italy

Location

Ospedale Regionale Torrette

Ancona, Italy

Location

Presidio Osp. Alto Garda e Ledro

Arco, Italy

Location

Centro Riferimento Oncologico

Aviano, Italy

Location

Istituto Oncologico Giovanni Paolo II

Bari, Italy

Location

Azienda Ospedaliera G. Rummo

Benevento, Italy

Location

Ospedale Fatebenefratelli

Benevento, Italy

Location

Ospedale Riuniti

Bergamo, Italy

Location

Ospedale degli Infermi

Biella, Italy

Location

Ospedale Regionale

Bolzano, Italy

Location

Policlinico Universitario

Cagliari, Italy

Location

Ospedale A. Cardarelli

Campobasso, Italy

Location

Ospedale Ramazzini

Carpi, Italy

Location

Centro Catanese di Oncologia

Catania, Italy

Location

Università di Chieti "D'Annunzio"

Chieti, Italy

Location

Ospedale Valduce

Como, Italy

Location

Ospedale Santa Croce

Fano, Italy

Location

Azienda Ospedaliera Universitaria

Ferrara, Italy

Location

Azienda Ospedale Careggi

Florence, Italy

Location

Azienda Ospedaliera Vito Fazzi

Lecce, Italy

Location

Ospedale Umberto I

Lugo, Italy

Location

Pres. Osp. di Manerbio

Manerbio, Italy

Location

Ospedale L. Sacco

Milan, Italy

Location

Ospedale San Paolo

Milan, Italy

Location

Ospedale G. Moscati

Monteforte Irpino, Italy

Location

Ospedale San Gerardo

Monza, Italy

Location

Istituto Nazionale Tumori

Napoli, Italy

Location

Ospedale Cardarelli

Napoli, Italy

Location

Ospedale Civile

Olbia, Italy

Location

Casa di Cura La Maddalena

Palermo, Italy

Location

Policlinico Giaccone

Palermo, Italy

Location

Ospedale San Salvatore-Muraglia

Pesaro, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Ospedale San Carlo

Potenza, Italy

Location

Azienda Policlinico S. Andrea

Roma, Italy

Location

Ospedale Fatebenefratelli

Roma, Italy

Location

Ospedale San Raffaele

Roma, Italy

Location

Policlinico Militare Celio

Roma, Italy

Location

Polo Oncologico Istituto Regina Elena

Roma, Italy

Location

Ospedale Civile

Rovereto, Italy

Location

Ospedale Civile

Rovigo, Italy

Location

Centro Oncologico

S. Vito Al Tagliamento, Italy

Location

Ospedale Santa Chiara

Trento, Italy

Location

Azienda Ospedaliera Treviglio-Caravaggio

Treviglio, Italy

Location

Ospedale San Bortolo

Vicenza, Italy

Location

Related Publications (1)

• 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.

  PMID: 20194854 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Giuseppe Colucci, M.D.

  Istituto Tumori Giovanni Paolo II

  PRINCIPAL INVESTIGATOR

• Roberto Labianca, M.D.

  Ospedale Riuniti Bergamo

  PRINCIPAL INVESTIGATOR

• Francesco Di Costanzo, M.D.

  Azienda Ospedaliera Careggi

  PRINCIPAL INVESTIGATOR

• Stefano Cascinu, M.D.

  Ospedale Riuniti Umberto I-Lancise-Salese

  PRINCIPAL INVESTIGATOR

• Paolo Pederzoli, M.D.

  Policlinico G.B. Rossi, Verona

  PRINCIPAL INVESTIGATOR

• Ciro Gallo, M.D., Ph.D.

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D.

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: April 1, 2002
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 23, 2008

Record last verified: 2008-12

Locations

IT (45)