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

December 22, 2008 updated by: Istituti Tumori Giovanni Paolo II

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • ARco, Italy
        • Presidio Osp. Alto Garda e Ledro
      • Acquaviva delle Fonti, Italy
        • Ospedal Miulli
      • Ancona, Italy
        • Ospedale Regionale Torrette
      • Aviano, Italy
        • Centro Riferimento Oncologico
      • Bari, Italy
        • Istituto Oncologico Giovanni Paolo II
      • Benevento, Italy
        • Ospedale Fatebenefratelli
      • Benevento, Italy
        • Azienda Ospedaliera G. Rummo
      • Bergamo, Italy
        • Ospedale Riuniti
      • Biella, Italy
        • Ospedale Degli Infermi
      • Bolzano, Italy
        • Ospedale Regionale
      • Cagliari, Italy
        • Policlinico Universitario
      • Campobasso, Italy
        • Ospedale A. Cardarelli
      • Carpi, Italy
        • Ospedale Ramazzini
      • Catania, Italy
        • Centro Catanese di Oncologia
      • Chieti, Italy
        • Università di Chieti "D'Annunzio"
      • Como, Italy
        • Ospedale Valduce
      • Fano, Italy
        • Ospedale Santa Croce
      • Ferrara, Italy
        • Azienda Ospedaliera Universitaria
      • Firenze, Italy
        • Azienda Ospedale Careggi
      • Lecce, Italy
        • Azienda Ospedaliera Vito Fazzi
      • Lugo, Italy
        • Ospedale Umberto I
      • Manerbio, Italy
        • Pres. Osp. di Manerbio
      • Milano, Italy
        • Ospedale L. Sacco
      • Milano, Italy
        • Ospedale San Paolo
      • Monteforte Irpino, Italy
        • Ospedale G. Moscati
      • Monza, Italy
        • Ospedale San Gerardo
      • Napoli, Italy
        • Ospedale Cardarelli
      • Napoli, Italy
        • Istituto Nazionale Tumori
      • Olbia, Italy
        • Ospedale Civile
      • Palermo, Italy
        • Casa di Cura La Maddalena
      • Palermo, Italy
        • Policlinico Giaccone
      • Pesaro, Italy
        • Ospedale San Salvatore-Muraglia
      • Piacenza, Italy
        • Ospedale Guglielmo da Saliceto
      • Potenza, Italy
        • Ospedale San Carlo
      • Roma, Italy
        • Ospedale Fatebenefratelli
      • Roma, Italy
        • Azienda Policlinico S. Andrea
      • Roma, Italy
        • Ospedale San Raffaele
      • Roma, Italy
        • Policlinico Militare Celio
      • Roma, Italy
        • Polo Oncologico Istituto Regina Elena
      • Rovereto, Italy
        • Ospedale Civile
      • Rovigo, Italy
        • Ospedale Civile
      • S. Vito al Tagliamento, Italy
        • Centro Oncologico
      • Trento, Italy
        • Ospedale Santa Chiara
      • Treviglio, Italy
        • Azienda Ospedaliera Treviglio-Caravaggio
      • Vicenza, Italy
        • Ospedale San Bortolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical benefit response
Time Frame: baseline and at end of every cycle of therapy
baseline and at end of every cycle of therapy
quality of life
Time Frame: baseline and at end of every cycle of therapy
baseline and at end of every cycle of therapy
objective response
Time Frame: after 7 weeks of therapy
after 7 weeks of therapy
time to progression
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Tumori Giovanni Paolo II

Collaborators

Gruppo Oncologico Italiano di Ricerca Clinica
Gruppo Oncologico Italia Meridionale
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (ANTICIPATED)

March 1, 2009

Study Completion (ANTICIPATED)

September 1, 2009

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 22, 2008

First Posted (ESTIMATE)

December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2008

Last Update Submitted That Met QC Criteria

December 22, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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