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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Istituti Tumori Giovanni Paolo II.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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
Information provided by:
Istituti Tumori Giovanni Paolo II
ClinicalTrials.gov Identifier:
NCT00813696
First received: December 22, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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 Intervention Phase
Pancreatic Cancer
 Drug: gemcitabine
Drug: cisplatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Istituti Tumori Giovanni Paolo II:

Primary Outcome Measures:
  • overall survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical benefit response [ Time Frame: baseline and at end of every cycle of therapy ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline and at end of every cycle of therapy ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: after 7 weeks of therapy ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: April 2002
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813696

Locations
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
Ospedale Cardarelli
Napoli, Italy
Istituto Nazionale Tumori
Napoli, Italy
Ospedale Civile
Olbia, Italy
Policlinico Giaccone
Palermo, Italy
Casa di Cura La Maddalena
Palermo, Italy
Ospedale San Salvatore-Muraglia
Pesaro, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Italy
Ospedale San Carlo
Potenza, Italy
Policlinico Militare Celio
Roma, Italy
Polo Oncologico Istituto Regina Elena
Roma, Italy
Azienda Policlinico S. Andrea
Roma, Italy
Ospedale Fatebenefratelli
Roma, Italy
Ospedale San Raffaele
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
Investigators
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. Second University of Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
  More Information

No publications provided by Istituti Tumori Giovanni Paolo II

Additional 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
Study First Received: December 22, 2008
Last Updated: December 22, 2008
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013