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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: 9 months
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituti Tumori Giovanni Paolo II

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2002

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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