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

Pancreatic Cancer Stage II Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043730
• Other study ID #: 2013-002973-23
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: January 14, 2019

Study information

• Verified date: October 2019
• Source: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 14, 2019
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer Stage II
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	A.O. Universitaria Ospedali Riuniti	Ancona	AN
Italy	Istituto Tumori Giovanni Paolo II	Bari	BA
Italy	A.O. Ospedale G.Rummo	Benevento	BN
Italy	A.O. Humanitas Gavazzeni	Bergamo	BG
Italy	AO Papa Giovanni XXIII	Bergamo
Italy	Ospedale degli Infermi	Biella
Italy	ASDAA Bolzano	Bolzano	BZ
Italy	Casa di Cura di Poliambulanza, Via Bissolati 57	Brescia
Italy	Ospedale di Circolo	Busto Arsizio	Varese
Italy	ULSS15 di Camposampiero/Cittadella	Camposampiero	PD
Italy	Azienda Ospedaliera Sant'Anna	Como	CO
Italy	Ospedale Civile degli Infermi	Faenza	Ravenna
Italy	Ospedale Santa Croce	Fano	Pesaro
Italy	A.O. Careggi-Università, Viale Pieraccini, 17	Firenze
Italy	A.O. Ospedale S.Martino	Genova	GE
Italy	A.O. Polo Oncologico Vito Fazzi	Lecce	LE
Italy	Ospedale Civile	Legnano	MI
Italy	Ospedale Umberto I	Lugo	Ravenna
Italy	Azienda Ospedaliera San Paolo	Milano	MI
Italy	Policlinico	Modena	MO
Italy	Policlinico Universitario D.Casula	Monserrato	Cagliari
Italy	Azienda Ospedaliera San Gerardo di Monza,	Monza	MB
Italy	AOU Policlinico Universitario Federico II	Napoli
Italy	INT-IRCCS Fondazione G.Pascale	Napoli
Italy	Azienda Ospedaluiera Universitaria	Parma	PR
Italy	IRCCS F.S. Maugeri	Pavia	PV
Italy	A.O. S.Salvatore	Pesaro	PS
Italy	AUSL di Piacenza	Piacenza	PC
Italy	Azienda Ospedaliera Ospedale San Carlo	Potenza	PZ
Italy	Azienda Ospedaliera	Ravenna	RA
Italy	A.O. S.Maria Nuova - IRCCS	Reggio Emilia	RE
Italy	A.O. S.Giovanni Calabita Fatebenefratelli	Roma
Italy	Azienda Policlinico Umberto I	Roma	RM
Italy	Policlinico Universitario A.Gemelli	Roma
Italy	Policlinico Universitario Campus Bio-Medico	Roma
Italy	Ospedale di Sondrio	Sondrio
Italy	A.O. Treviglio-Caravaggio, P.le Ospedale n1	Treviglio	Bergamo
Italy	A.O. Cà Foncello	Treviso	TV
Italy	Ospedale Civile	Vigevano	PV

Sponsors (3)

Lead Sponsor	Collaborator
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente	Istituto Nazionale Tumori di Napoli, Unità Sperimentazioni cliniche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression rate is evaluated after 3 cycles of chemotherapy
Secondary	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	Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy
Secondary	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	every 3 cycles of chemotherapy
Secondary	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	time from the start of the treatment until PD or death
Secondary	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).	the time from randomization to the date of death