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Pancreatic CancerPhase 3GIP-1NCT00813696

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

A Phase 3 study testing gemcitabine and cisplatin in people with Pancreatic Cancer, run by Istituti Tumori Giovanni Paolo II at 45 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
gemcitabine and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
45 sitesItaly
Study dates
Apr 2002to Sep 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

Italy45 sites

  • Ospedal Miulli

    Acquaviva delle Fonti

  • Ospedale Regionale Torrette

    Ancona

  • Presidio Osp. Alto Garda e Ledro

    Arco

  • Centro Riferimento Oncologico

    Aviano

  • Istituto Oncologico Giovanni Paolo II

    Bari

  • Azienda Ospedaliera G. Rummo

    Benevento

  • Ospedale Fatebenefratelli

    Benevento

  • Ospedale Riuniti

    Bergamo

  • Ospedale degli Infermi

    Biella

  • Ospedale Regionale

    Bolzano

  • Policlinico Universitario

    Cagliari

  • Ospedale A. Cardarelli

    Campobasso

  • Ospedale Ramazzini

    Carpi

  • Centro Catanese di Oncologia

    Catania

  • Università di Chieti "D'Annunzio"

    Chieti

  • Ospedale Valduce

    Como

  • Ospedale Santa Croce

    Fano

  • Azienda Ospedaliera Universitaria

    Ferrara

  • Azienda Ospedale Careggi

    Florence

  • Azienda Ospedaliera Vito Fazzi

    Lecce

  • Ospedale Umberto I

    Lugo

  • Pres. Osp. di Manerbio

    Manerbio

  • Ospedale L. Sacco

    Milan

  • Ospedale San Paolo

    Milan

  • Ospedale G. Moscati

    Monteforte Irpino

  • Ospedale San Gerardo

    Monza

  • Istituto Nazionale Tumori

    Naples

  • Ospedale Cardarelli

    Naples

  • Ospedale Civile

    Olbia

  • Casa di Cura La Maddalena

    Palermo

  • Policlinico Giaccone

    Palermo

  • Ospedale San Salvatore-Muraglia

    Pesaro

  • Ospedale Guglielmo da Saliceto

    Piacenza

  • Ospedale San Carlo

    Potenza

  • Azienda Policlinico S. Andrea

    Roma

  • Ospedale Fatebenefratelli

    Roma

  • Ospedale San Raffaele

    Roma

  • Policlinico Militare Celio

    Roma

  • Polo Oncologico Istituto Regina Elena

    Roma

  • Ospedale Civile

    Rovereto

  • Ospedale Civile

    Rovigo

  • Centro Oncologico

    S. Vito Al Tagliamento

  • Ospedale Santa Chiara

    Trento

  • Azienda Ospedaliera Treviglio-Caravaggio

    Treviglio

  • Ospedale San Bortolo

    Vicenza

Other trials in Italy

About this study

Official title: 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.

Being tested
gemcitabine, cisplatin
Keywords
chemotherapy, advanced cancer, inoperable, Stage II, III, IV
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabineDrug

    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

  • cisplatinDrug

    25 mg/m2 IV on days 1, 8, and 15 every 4 weeks

Study groups in NCT00813696
Study groupRoleWhat they receive
AExperimentalcisplatin + gemcitabine
Receives: Drug: gemcitabine; Drug: cisplatin
BActive comparatorgemcitabine
Receives: Drug: gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: 9 months

Secondary outcomes (4)

  1. clinical benefit response

    Measured: baseline and at end of every cycle of therapy

  2. quality of life

    Measured: baseline and at end of every cycle of therapy

  3. objective response

    Measured: after 7 weeks of therapy

  4. time to progression

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2008 (estimated)
  2. Study startApr 2002
  3. Primary completionMar 2009 (estimated)
  4. Study completionSep 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00813696
Sponsor's protocol ID
GIP-1
Acronym
GIP-1
Status last verified
Dec 2008
First submitted
22 Dec 2008
Last updated
23 Dec 2008
Results posted
No
Data monitoring committee
No

Publications

  • Colucci G, Labianca R, Di Costanzo F, Gebbia V, Carteni G, Massidda B, Dapretto E, Manzione L, Piazza E, Sannicolo M, Ciaparrone M, Cavanna L, Giuliani F, Maiello E, Testa A, Pederzoli P, Falconi M, Gallo C, Di Maio M, Perrone F; Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 2010 Apr 1;28(10):1645-51. doi: 10.1200/JCO.2009.25.4433. Epub 2010 Mar 1.

    PubMed 20194854

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine and cisplatin in people with Pancreatic Cancer, run by Istituti Tumori Giovanni Paolo II at 45 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00813696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2008; AzTrials last refreshed its copy on 8 Nov 2026.

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