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

Pancreatic Cancer Clinical Trial

— GIP-1  

Official title:

Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00813696
• Other study ID #: GIP-1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: December 22, 2008
• Last updated: December 22, 2008
• Start date: April 2002
• Est. completion date: September 2009

Study information

• Verified date: December 2008
• Source: Istituti Tumori Giovanni Paolo II
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	Azienda Ospedaliera Vito Fazzi	Lecce
Italy	Ospedale Umberto I	Lugo
Italy	Pres. Osp. di Manerbio	Manerbio
Italy	Ospedale L. Sacco	Milano
Italy	Ospedale San Paolo	Milano
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

Sponsors (5)

Lead Sponsor	Collaborator
Istituti Tumori Giovanni Paolo II	Cattedra di Endocrinochirurgia, Università di Verona, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico Italia Meridionale, Gruppo Oncologico Italiano di Ricerca Clinica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		9 months	No
Secondary	clinical benefit response		baseline and at end of every cycle of therapy	No
Secondary	quality of life		baseline and at end of every cycle of therapy	No
Secondary	objective response		after 7 weeks of therapy	No
Secondary	time to progression		6 months	No