Clinical trial NCT02043730: Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer Stage II
Keywords: pancreatic cancer
locally advanced
unresectable cancer
Lead sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Sponsor class: OTHER
Collaborators: name: Unità Sperimentazioni cliniche
name: Istituto Nazionale Tumori di Napoli
First posted: 2014-01-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Progression Rate
timeFrame: progression rate is evaluated after 3 cycles of chemotherapy
Secondary outcomes:
measure: Quality of Response
timeFrame: Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
measure: Esplore the effects of nab-paclitaxel in terms of toxicity
timeFrame: every 3 cycles of chemotherapy
measure: Progression Free Survival
timeFrame: time from the start of the treatment until PD or death
measure: Overall Survival
timeFrame: the time from randomization to the date of death
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: A.O. Universitaria Ospedali Riuniti
state: AN
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II
state: BA
city: Treviglio
country: Italy
facility: A.O. Treviglio-Caravaggio, P.le Ospedale n1
state: Bergamo
city: Bergamo
country: Italy
facility: A.O. Humanitas Gavazzeni
state: BG
city: Benevento
country: Italy
facility: A.O. Ospedale G.Rummo
state: BN
city: Bolzano
country: Italy
facility: ASDAA Bolzano
state: BZ
city: Monserrato
country: Italy
facility: Policlinico Universitario D.Casula
state: Cagliari
city: Como
country: Italy
facility: Azienda Ospedaliera Sant'Anna
state: CO
city: Genova
country: Italy
facility: A.O. Ospedale S.Martino
state: GE
city: Lecce
country: Italy
facility: A.O. Polo Oncologico Vito Fazzi
state: LE
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo di Monza,
state: MB
city: Legnano
country: Italy
facility: Ospedale Civile
state: MI
city: Milano
country: Italy
facility: Azienda Ospedaliera San Paolo
state: MI
city: Modena
country: Italy
facility: Policlinico
state: MO
city: Piacenza
country: Italy
facility: AUSL di Piacenza
state: PC
city: Camposampiero
country: Italy
facility: ULSS15 di Camposampiero/Cittadella
state: PD
city: Fano
country: Italy
facility: Ospedale Santa Croce
state: Pesaro
city: Parma
country: Italy
facility: Azienda Ospedaluiera Universitaria
state: PR
city: Pesaro
country: Italy
facility: A.O. S.Salvatore
state: PS
city: Pavia
country: Italy
facility: IRCCS F.S. Maugeri
state: PV
city: Vigevano
country: Italy
facility: Ospedale Civile
state: PV
city: Potenza
country: Italy
facility: Azienda Ospedaliera Ospedale San Carlo
state: PZ
city: Faenza
country: Italy
facility: Ospedale Civile degli Infermi
state: Ravenna
city: Lugo
country: Italy
facility: Ospedale Umberto I
state: Ravenna
city: Ravenna
country: Italy
facility: Azienda Ospedaliera
state: RA
city: Reggio Emilia
country: Italy
facility: A.O. S.Maria Nuova - IRCCS
state: RE
city: Roma
country: Italy
facility: Azienda Policlinico Umberto I
state: RM
city: Treviso
country: Italy
facility: A.O. Cà Foncello
state: TV
city: Busto Arsizio
country: Italy
facility: Ospedale di Circolo
state: Varese
city: Bergamo
country: Italy
facility: AO Papa Giovanni XXIII
city: Biella
country: Italy
facility: Ospedale degli Infermi
city: Brescia
country: Italy
facility: Casa di Cura di Poliambulanza, Via Bissolati 57
city: Firenze
country: Italy
facility: A.O. Careggi-Università, Viale Pieraccini, 17
city: Napoli
country: Italy
facility: AOU Policlinico Universitario Federico II
city: Napoli
country: Italy
facility: INT-IRCCS Fondazione G.Pascale
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: Policlinico Universitario A.Gemelli
city: Roma
country: Italy
facility: A.O. S.Giovanni Calabita Fatebenefratelli
city: Sondrio
country: Italy
facility: Ospedale di Sondrio
Study officials:
affiliation: GISCAD Foundation
name: Stefano Cascinu, PhD
role: STUDY_CHAIR
References:
citation: 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.