We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer (GIP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00813696
Recruitment Status : Unknown
Verified December 2008 by Istituti Tumori Giovanni Paolo II.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2008
Last Update Posted : December 23, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine Drug: cisplatin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Study Start Date : April 2002
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
cisplatin + gemcitabine
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
Drug: cisplatin
25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
Active Comparator: B
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

Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. clinical benefit response [ Time Frame: baseline and at end of every cycle of therapy ]
  2. quality of life [ Time Frame: baseline and at end of every cycle of therapy ]
  3. objective response [ Time Frame: after 7 weeks of therapy ]
  4. time to progression [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813696

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, Italy
Sponsors and Collaborators
Istituti Tumori Giovanni Paolo II
Gruppo Oncologico Italia Meridionale
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Gruppo Oncologico Italiano di Ricerca Clinica
Cattedra di Endocrinochirurgia, Università di Verona
Principal Investigator: 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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giuseppe Colucci, GOIM
ClinicalTrials.gov Identifier: NCT00813696     History of Changes
Other Study ID Numbers: GIP-1
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008

Keywords provided by Istituti Tumori Giovanni Paolo II:
advanced cancer
Stage II, III, IV

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs