AzTrials
AzTrials

Pancreatic Cancer Stage IIPhase 2GAPNCT02043730

Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

A Phase 2 study testing Nab-paclitaxel and Gemcitabine and Gemcitabine in people with Pancreatic Cancer Stage II, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 39 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management. Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer Stage II
What is being tested?
Nab-paclitaxel and Gemcitabine and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
39 sitesItaly
Study dates
Jan 2014to 14 Jan 2019
Phase
Phase 2
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

  • Written informed consent
  • Age >18 < 75 years
  • Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  • At least one lesion measurable with CT or MRI scan
  • Performance Status (ECOG) 0-1 at study entry
  • Life expectancy of at least 3 months
  • Adequate marrow, liver and renal function
  • Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported)

Who cannot join

  • Previous chemotherapy or radiotherapy for pancreatic cancer
  • Severe cardiovascular disease
  • Thrombotic or embolic events
  • Acute or subacute intestinal occlusion or history of inflammatory bowel disease
  • Known hypersensitivity to study drug
  • Known drugs or alcohol abuse
Show all 9Show fewer
  • Pregnant or breastfeeding women
  • Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
  • Unable to sign informed consent

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Italy39 sites

  • A.O. Universitaria Ospedali Riuniti

    Ancona, AN, 60100

  • Istituto Tumori Giovanni Paolo II

    Bari, BA, 70124

  • A.O. Ospedale G.Rummo

    Benevento, BN, 82100

  • A.O. Humanitas Gavazzeni

    Bergamo, BG, 24125

  • AO Papa Giovanni XXIII

    Bergamo, 24100

  • Ospedale degli Infermi

    Biella, 13900

  • ASDAA Bolzano

    Bolzano, BZ, 39100

  • Casa di Cura di Poliambulanza, Via Bissolati 57

    Brescia, 25100

  • Ospedale di Circolo

    Busto Arsizio, Varese, 21051

  • ULSS15 di Camposampiero/Cittadella

    Camposampiero, PD, 35012

  • Azienda Ospedaliera Sant'Anna

    Como, CO, 22020

  • Ospedale Civile degli Infermi

    Faenza, Ravenna, 48014

  • Ospedale Santa Croce

    Fano, Pesaro, 61032

  • A.O. Careggi-Università, Viale Pieraccini, 17

    Florence, 50139

  • A.O. Ospedale S.Martino

    Genova, GE, 16132

  • A.O. Polo Oncologico Vito Fazzi

    Lecce, LE, 73100

  • Ospedale Civile

    Legnano, MI, 20025

  • Ospedale Umberto I

    Lugo, Ravenna, 48022

  • Azienda Ospedaliera San Paolo

    Milan, MI, 20142

  • Policlinico

    Modena, MO, 41142

  • Policlinico Universitario D.Casula

    Monserrato, Cagliari, 09121

  • Azienda Ospedaliera San Gerardo di Monza,

    Monza, MB, 20900

  • AOU Policlinico Universitario Federico II

    Naples, 80131

  • INT-IRCCS Fondazione G.Pascale

    Naples, 80131

  • Azienda Ospedaluiera Universitaria

    Parma, PR, 43126

  • IRCCS F.S. Maugeri

    Pavia, PV, 27100

  • A.O. S.Salvatore

    Pesaro, PS, 61100

  • AUSL di Piacenza

    Piacenza, PC, 29100

  • Azienda Ospedaliera Ospedale San Carlo

    Potenza, PZ, 85100

  • Azienda Ospedaliera

    Ravenna, RA, 48121

  • A.O. S.Maria Nuova - IRCCS

    Reggio Emilia, RE, 42100

  • Azienda Policlinico Umberto I

    Roma, RM, 00161

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • Policlinico Universitario A.Gemelli

    Roma, 00168

  • A.O. S.Giovanni Calabita Fatebenefratelli

    Roma, 00186

  • Ospedale di Sondrio

    Sondrio, 23100

  • A.O. Treviglio-Caravaggio, P.le Ospedale n1

    Treviglio, Bergamo, 24047

  • A.O. Cà Foncello

    Treviso, TV

  • Ospedale Civile

    Vigevano, PV, 27029

Other trials in Italy

About this study

Official title: A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial

Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.

Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.

Read the detailed description

Study population: Locally advanced unresectable pancreatic cancer patients

Elegibility criteria:

  • Written informed consent
  • Age >18 < 75 years
  • Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  • At least one lesion measurable with CT or MRI scan
  • Performance Status (ECOG) 0-1 at study entry
  • Life expectancy of at least 3 months
  • Adequate marrow, liver and renal function
  • Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported
Being tested
Nab-paclitaxel and Gemcitabine, Gemcitabine
Keywords
pancreatic cancer, locally advanced, unresectable cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Nab-paclitaxel and GemcitabineDrug

    Also called abraxane, gemzar

    Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle

  • GemcitabineDrug

    Also called gemzar

    gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Study groups in NCT02043730
Study groupRoleWhat they receive
nab-paclitaxel and gemcitabineExperimentalARM A: nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle
Receives: Drug: Nab-paclitaxel and Gemcitabine; Drug: Gemcitabine
GemcitabineActive comparatorARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Receives: Drug: Gemcitabine

What is being measured

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

  1. Progression Rate

    Assuming an expected progression rate in the control arm of 40% and an auspicated progression rate in the experimental arm of 20%,with one-tailed alpha=0.05, 80% power, 124 patients are required for the final analysis

    Measured: progression rate is evaluated after 3 cycles of chemotherapy

Secondary outcomes (4)

  1. Quality of Response

    All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

    Measured: Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy

  2. Esplore the effects of nab-paclitaxel in terms of toxicity

    Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade

    Measured: every 3 cycles of chemotherapy

  3. Progression Free Survival

    Progression free survival time will be defined as the time from randomization until the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented.

    Patients who did not progress will be censored at the last date they were known to be alive.

    Patients who died of disease and for whom a date of progression is not available will be considered to have progressed on the day of their death

    Measured: time from the start of the treatment until PD or death

  4. Overall Survival

    Overall survival time will be defined as the time from randomization to the date of death. If the subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow up).

    Measured: the time from randomization to the date of death

Timeline

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

  1. First posted23 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2016
  4. Study completion14 Jan 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02043730
Sponsor's protocol ID
2013-002973-23
Acronym
GAP
Status last verified
Oct 2019
First submitted
14 Jan 2014
Last updated
9 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • Cascinu S, Berardi R, Bianco R, Bilancia D, Zaniboni A, Ferrari D, Mosconi S, Spallanzani A, Cavanna L, Leo S, Negri F, Beretta GD, Sobrero A, Banzi M, Morabito A, Bittoni A, Marciano R, Ferrara D, Noventa S, Piccirillo MC, Labianca R, Mosconi C, Casadei Gardini A, Gallo C, Perrone F. Nab-paclitaxel/gemcitabine combination is more effective than gemcitabine alone in locally advanced, unresectable pancreatic cancer - A GISCAD phase II randomized trial. Eur J Cancer. 2021 May;148:422-429. doi: 10.1016/j.ejca.2021.02.023. Epub 2021 Mar 31.

    PubMed 33812334

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-paclitaxel and Gemcitabine and Gemcitabine in people with Pancreatic Cancer Stage II, run by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente at 39 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression Rate (time frame: progression rate is evaluated after 3 cycles of chemotherapy). 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 NCT02043730, 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 9 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in