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

Primary Purpose

Pancreatic Cancer Stage II

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Nab-paclitaxel and Gemcitabine
Gemcitabine
Sponsored by
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Stage II focused on measuring pancreatic cancer, locally advanced, unresectable cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O. Universitaria Ospedali Riuniti
  • Istituto Tumori Giovanni Paolo II
  • A.O. Treviglio-Caravaggio, P.le Ospedale n1
  • A.O. Humanitas Gavazzeni
  • A.O. Ospedale G.Rummo
  • ASDAA Bolzano
  • Policlinico Universitario D.Casula
  • Azienda Ospedaliera Sant'Anna
  • A.O. Ospedale S.Martino
  • A.O. Polo Oncologico Vito Fazzi
  • Azienda Ospedaliera San Gerardo di Monza,
  • Ospedale Civile
  • Azienda Ospedaliera San Paolo
  • Policlinico
  • AUSL di Piacenza
  • ULSS15 di Camposampiero/Cittadella
  • Ospedale Santa Croce
  • Azienda Ospedaluiera Universitaria
  • A.O. S.Salvatore
  • IRCCS F.S. Maugeri
  • Ospedale Civile
  • Azienda Ospedaliera Ospedale San Carlo
  • Ospedale Civile degli Infermi
  • Ospedale Umberto I
  • Azienda Ospedaliera
  • A.O. S.Maria Nuova - IRCCS
  • Azienda Policlinico Umberto I
  • A.O. Cà Foncello
  • Ospedale di Circolo
  • AO Papa Giovanni XXIII
  • Ospedale degli Infermi
  • Casa di Cura di Poliambulanza, Via Bissolati 57
  • A.O. Careggi-Università, Viale Pieraccini, 17
  • AOU Policlinico Universitario Federico II
  • INT-IRCCS Fondazione G.Pascale
  • Policlinico Universitario Campus Bio-Medico
  • Policlinico Universitario A.Gemelli
  • A.O. S.Giovanni Calabita Fatebenefratelli
  • Ospedale di Sondrio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nab-paclitaxel and gemcitabine

Gemcitabine

Arm Description

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

ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Outcomes

Primary Outcome Measures

Progression Rate
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

Quality of Response
All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations
Esplore the effects of nab-paclitaxel in terms of toxicity
Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade
Progression Free Survival
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
Overall Survival
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).

Full Information

First Posted
January 14, 2014
Last Updated
October 7, 2019
Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Unità Sperimentazioni cliniche, Istituto Nazionale Tumori di Napoli
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1. Study Identification

Unique Protocol Identification Number
NCT02043730
Brief Title
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
Acronym
GAP
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
January 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators
Unità Sperimentazioni cliniche, Istituto Nazionale Tumori di Napoli

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Stage II
Keywords
pancreatic cancer, locally advanced, unresectable cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nab-paclitaxel and gemcitabine
Arm Type
Experimental
Arm Description
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
Arm Title
Gemcitabine
Arm Type
Active Comparator
Arm Description
ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel and Gemcitabine
Other Intervention Name(s)
abraxane, gemzar
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
gemzar
Intervention Description
gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
Primary Outcome Measure Information:
Title
Progression Rate
Description
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
Time Frame
progression rate is evaluated after 3 cycles of chemotherapy
Secondary Outcome Measure Information:
Title
Quality of Response
Description
All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations
Time Frame
Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
Title
Esplore the effects of nab-paclitaxel in terms of toxicity
Description
Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade
Time Frame
every 3 cycles of chemotherapy
Title
Progression Free Survival
Description
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 Frame
time from the start of the treatment until PD or death
Title
Overall Survival
Description
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).
Time Frame
the time from randomization to the date of death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Cascinu, PhD
Organizational Affiliation
GISCAD Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
A.O. Universitaria Ospedali Riuniti
City
Ancona
State/Province
AN
ZIP/Postal Code
60100
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
A.O. Treviglio-Caravaggio, P.le Ospedale n1
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Facility Name
A.O. Humanitas Gavazzeni
City
Bergamo
State/Province
BG
ZIP/Postal Code
24125
Country
Italy
Facility Name
A.O. Ospedale G.Rummo
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
ASDAA Bolzano
City
Bolzano
State/Province
BZ
ZIP/Postal Code
39100
Country
Italy
Facility Name
Policlinico Universitario D.Casula
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Anna
City
Como
State/Province
CO
ZIP/Postal Code
22020
Country
Italy
Facility Name
A.O. Ospedale S.Martino
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Polo Oncologico Vito Fazzi
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo di Monza,
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Facility Name
Ospedale Civile
City
Legnano
State/Province
MI
ZIP/Postal Code
20025
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Facility Name
Policlinico
City
Modena
State/Province
MO
ZIP/Postal Code
41142
Country
Italy
Facility Name
AUSL di Piacenza
City
Piacenza
State/Province
PC
ZIP/Postal Code
29100
Country
Italy
Facility Name
ULSS15 di Camposampiero/Cittadella
City
Camposampiero
State/Province
PD
ZIP/Postal Code
35012
Country
Italy
Facility Name
Ospedale Santa Croce
City
Fano
State/Province
Pesaro
ZIP/Postal Code
61032
Country
Italy
Facility Name
Azienda Ospedaluiera Universitaria
City
Parma
State/Province
PR
ZIP/Postal Code
43126
Country
Italy
Facility Name
A.O. S.Salvatore
City
Pesaro
State/Province
PS
ZIP/Postal Code
61100
Country
Italy
Facility Name
IRCCS F.S. Maugeri
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Civile
City
Vigevano
State/Province
PV
ZIP/Postal Code
27029
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale San Carlo
City
Potenza
State/Province
PZ
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale Civile degli Infermi
City
Faenza
State/Province
Ravenna
ZIP/Postal Code
48014
Country
Italy
Facility Name
Ospedale Umberto I
City
Lugo
State/Province
Ravenna
ZIP/Postal Code
48022
Country
Italy
Facility Name
Azienda Ospedaliera
City
Ravenna
State/Province
RA
ZIP/Postal Code
48121
Country
Italy
Facility Name
A.O. S.Maria Nuova - IRCCS
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42100
Country
Italy
Facility Name
Azienda Policlinico Umberto I
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O. Cà Foncello
City
Treviso
State/Province
TV
Country
Italy
Facility Name
Ospedale di Circolo
City
Busto Arsizio
State/Province
Varese
ZIP/Postal Code
21051
Country
Italy
Facility Name
AO Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Ospedale degli Infermi
City
Biella
ZIP/Postal Code
13900
Country
Italy
Facility Name
Casa di Cura di Poliambulanza, Via Bissolati 57
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
A.O. Careggi-Università, Viale Pieraccini, 17
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
AOU Policlinico Universitario Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
INT-IRCCS Fondazione G.Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Policlinico Universitario A.Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O. S.Giovanni Calabita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy
Facility Name
Ospedale di Sondrio
City
Sondrio
ZIP/Postal Code
23100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33812334
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.
Results Reference
derived

Learn more about this trial

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

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