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

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ClinicalTrials.gov Identifier: NCT02043730
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Unità Sperimentazioni cliniche
Istituto Nazionale Tumori di Napoli
Information provided by (Responsible Party):
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

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
Pancreatic Cancer Stage II Drug: Nab-paclitaxel and Gemcitabine Drug: Gemcitabine 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

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Study Type : Interventional  (Clinical Trial)
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 : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : January 14, 2019


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 Name: 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 Name: gemzar




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


  4. 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043730


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

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Responsible Party: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
ClinicalTrials.gov Identifier: NCT02043730     History of Changes
Other Study ID Numbers: 2013-002973-23
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente:
pancreatic cancer
locally advanced
unresectable cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs