Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
NCT ID: NCT02043730
Last Updated: 2019-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
124 participants
INTERVENTIONAL
2014-01-31
2019-01-14
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Gemcitabine
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Gemcitabine
ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Gemcitabine
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Interventions
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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
Gemcitabine
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Unità Sperimentazioni cliniche
UNKNOWN
Istituto Nazionale Tumori di Napoli
UNKNOWN
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
OTHER
Responsible Party
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Principal Investigators
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Stefano Cascinu, PhD
Role: STUDY_CHAIR
GISCAD Foundation
Locations
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A.O. Universitaria Ospedali Riuniti
Ancona, AN, Italy
Istituto Tumori Giovanni Paolo II
Bari, BA, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, Italy
A.O. Humanitas Gavazzeni
Bergamo, BG, Italy
A.O. Ospedale G.Rummo
Benevento, BN, Italy
ASDAA Bolzano
Bolzano, BZ, Italy
Policlinico Universitario D.Casula
Monserrato, Cagliari, Italy
Azienda Ospedaliera Sant'Anna
Como, CO, Italy
A.O. Ospedale S.Martino
Genova, GE, Italy
A.O. Polo Oncologico Vito Fazzi
Lecce, LE, Italy
Azienda Ospedaliera San Gerardo di Monza,
Monza, MB, Italy
Ospedale Civile
Legnano, MI, Italy
Azienda Ospedaliera San Paolo
Milan, MI, Italy
Policlinico
Modena, MO, Italy
AUSL di Piacenza
Piacenza, PC, Italy
ULSS15 di Camposampiero/Cittadella
Camposampiero, PD, Italy
Ospedale Santa Croce
Fano, Pesaro, Italy
Azienda Ospedaluiera Universitaria
Parma, PR, Italy
A.O. S.Salvatore
Pesaro, PS, Italy
IRCCS F.S. Maugeri
Pavia, PV, Italy
Ospedale Civile
Vigevano, PV, Italy
Azienda Ospedaliera Ospedale San Carlo
Potenza, PZ, Italy
Ospedale Civile degli Infermi
Faenza, Ravenna, Italy
Ospedale Umberto I
Lugo, Ravenna, Italy
Azienda Ospedaliera
Ravenna, RA, Italy
A.O. S.Maria Nuova - IRCCS
Reggio Emilia, RE, Italy
Azienda Policlinico Umberto I
Roma, RM, Italy
A.O. Cà Foncello
Treviso, TV, Italy
Ospedale di Circolo
Busto Arsizio, Varese, Italy
AO Papa Giovanni XXIII
Bergamo, , Italy
Ospedale degli Infermi
Biella, , Italy
Casa di Cura di Poliambulanza, Via Bissolati 57
Brescia, , Italy
A.O. Careggi-Università, Viale Pieraccini, 17
Florence, , Italy
AOU Policlinico Universitario Federico II
Napoli, , Italy
INT-IRCCS Fondazione G.Pascale
Napoli, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Policlinico Universitario A.Gemelli
Roma, , Italy
A.O. S.Giovanni Calabita Fatebenefratelli
Roma, , Italy
Ospedale di Sondrio
Sondrio, , Italy
Countries
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References
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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.
Other Identifiers
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2013-002973-23
Identifier Type: -
Identifier Source: org_study_id
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