Clincosm LogoSign in Get a demo

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

Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente (Other)
Overall Status
Completed
CT.gov ID
NCT02043730
Collaborator
Unità Sperimentazioni cliniche (Other), Istituto Nazionale Tumori di Napoli (Other)
124
Enrollment
39
Locations
2
Arms
60.4
Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Jan 14, 2019

Arms and Interventions

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:
  • abraxane
  • gemzar

    • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression Rate [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

    Secondary Outcome Measures

    1. Quality of Response [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

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

    3. Progression Free Survival [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

    4. Overall Survival [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
    • Unità Sperimentazioni cliniche
    • Istituto Nazionale Tumori di Napoli

    Investigators

    • Study Chair: Stefano Cascinu, PhD, GISCAD Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
    ClinicalTrials.gov Identifier:
    NCT02043730
    Other Study ID Numbers:
    • 2013-002973-23
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Oct 9, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
    pancreatic cancer
    locally advanced
    unresectable cancer
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Gemcitabine
    Paclitaxel

    Study Results

    No Results Posted as of Oct 9, 2019