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

October 7, 2019 updated by: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

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
      • Bergamo, Italy, 24100
        • AO Papa Giovanni XXIII
      • Biella, Italy, 13900
        • Ospedale degli Infermi
      • Brescia, Italy, 25100
        • Casa di Cura di Poliambulanza, Via Bissolati 57
      • Firenze, Italy, 50139
        • A.O. Careggi-Università, Viale Pieraccini, 17
      • Napoli, Italy, 80131
        • AOU Policlinico Universitario Federico II
      • Napoli, Italy, 80131
        • INT-IRCCS Fondazione G.Pascale
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Roma, Italy, 00168
        • Policlinico Universitario A.Gemelli
      • Roma, Italy, 00186
        • A.O. S.Giovanni Calabita Fatebenefratelli
      • Sondrio, Italy, 23100
        • Ospedale di Sondrio
    • AN
      • Ancona, AN, Italy, 60100
        • A.O. Universitaria Ospedali Riuniti
    • BA
      • Bari, BA, Italy, 70124
        • Istituto Tumori Giovanni Paolo II
    • BG
      • Bergamo, BG, Italy, 24125
        • A.O. Humanitas Gavazzeni
    • BN
      • Benevento, BN, Italy, 82100
        • A.O. Ospedale G.Rummo
    • BZ
      • Bolzano, BZ, Italy, 39100
        • ASDAA Bolzano
    • Bergamo
      • Treviglio, Bergamo, Italy, 24047
        • A.O. Treviglio-Caravaggio, P.le Ospedale n1
    • CO
      • Como, CO, Italy, 22020
        • Azienda Ospedaliera Sant'Anna
    • Cagliari
      • Monserrato, Cagliari, Italy, 09121
        • Policlinico Universitario D.Casula
    • GE
      • Genova, GE, Italy, 16132
        • A.O. Ospedale S.Martino
    • LE
      • Lecce, LE, Italy, 73100
        • A.O. Polo Oncologico Vito Fazzi
    • MB
      • Monza, MB, Italy, 20900
        • Azienda Ospedaliera San Gerardo di Monza,
    • MI
      • Legnano, MI, Italy, 20025
        • Ospedale Civile
      • Milano, MI, Italy, 20142
        • Azienda Ospedaliera San Paolo
    • MO
      • Modena, MO, Italy, 41142
        • Policlinico
    • PC
      • Piacenza, PC, Italy, 29100
        • AUSL di Piacenza
    • PD
      • Camposampiero, PD, Italy, 35012
        • ULSS15 di Camposampiero/Cittadella
    • PR
      • Parma, PR, Italy, 43126
        • Azienda Ospedaluiera Universitaria
    • PS
      • Pesaro, PS, Italy, 61100
        • A.O. S.Salvatore
    • PV
      • Pavia, PV, Italy, 27100
        • IRCCS F.S. Maugeri
      • Vigevano, PV, Italy, 27029
        • Ospedale Civile
    • PZ
      • Potenza, PZ, Italy, 85100
        • Azienda Ospedaliera Ospedale San Carlo
    • Pesaro
      • Fano, Pesaro, Italy, 61032
        • Ospedale Santa Croce
    • RA
      • Ravenna, RA, Italy, 48121
        • Azienda Ospedaliera
    • RE
      • Reggio Emilia, RE, Italy, 42100
        • A.O. S.Maria Nuova - IRCCS
    • RM
      • Roma, RM, Italy, 00161
        • Azienda Policlinico Umberto I
    • Ravenna
      • Faenza, Ravenna, Italy, 48014
        • Ospedale Civile degli Infermi
      • Lugo, Ravenna, Italy, 48022
        • Ospedale Umberto I
    • TV
      • Treviso, TV, Italy
        • A.O. Cà Foncello
    • Varese
      • Busto Arsizio, Varese, Italy, 21051
        • Ospedale Di Circolo

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion 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)

Exclusion Criteria:

  • 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
  • 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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nab-paclitaxel and gemcitabine
ARM 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
Drug: Nab-paclitaxel and Gemcitabine
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
Other Names:
  • gemzar
  • abraxane
Drug: Gemcitabine
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Other Names:
  • gemzar
Active Comparator: Gemcitabine
ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Drug: Gemcitabine
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Other Names:
  • gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Rate
Time Frame: progression rate is evaluated after 3 cycles of chemotherapy
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
progression rate is evaluated after 3 cycles of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Response
Time Frame: Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations
Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
Esplore the effects of nab-paclitaxel in terms of toxicity
Time Frame: every 3 cycles of chemotherapy
Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade
every 3 cycles of chemotherapy
Progression Free Survival
Time Frame: time from the start of the treatment until PD or death

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
time from the start of the treatment until PD or death
Overall Survival
Time Frame: the time from randomization to the date of death
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).
the time from randomization to the date of death

Collaborators and Investigators

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

Sponsor

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Collaborators

Unità Sperimentazioni cliniche
Istituto Nazionale Tumori di Napoli

Investigators

  • Study Chair: Stefano Cascinu, PhD, GISCAD Foundation

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

January 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

January 14, 2019

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-002973-23

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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