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

Phase 2

Completed

• Conditions: Pancreatic Cancer Stage II
• Interventions: Drug: Nab-paclitaxel and Gemcitabine; Drug: Gemcitabine

• Registration Number: NCT02043730
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2016-03
• Study Completion: 2019-01-14
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression Rate	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

Name	Time	Method
Quality of Response	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
Esplore the effects of nab-paclitaxel in terms of toxicity	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
Progression Free Survival	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
Overall Survival	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).

Trial Locations

Locations (38)

A.O. Treviglio-Caravaggio, P.le Ospedale n1; 🇮🇹 Treviglio, Bergamo, Italy

Azienda Ospedaliera Sant'Anna; 🇮🇹 Como, CO, Italy

Policlinico Universitario D.Casula; 🇮🇹 Monserrato, Cagliari, Italy

Policlinico; 🇮🇹 Modena, MO, Italy

AUSL di Piacenza; 🇮🇹 Piacenza, PC, Italy

Ospedale Santa Croce; 🇮🇹 Fano, Pesaro, Italy

A.O. Polo Oncologico Vito Fazzi; 🇮🇹 Lecce, LE, Italy

Azienda Ospedaliera San Gerardo di Monza,; 🇮🇹 Monza, MB, Italy

Ospedale Civile; 🇮🇹 Vigevano, PV, Italy

Ospedale Civile degli Infermi; 🇮🇹 Faenza, Ravenna, Italy

Ospedale Umberto I; 🇮🇹 Lugo, Ravenna, Italy

Ospedale di Circolo; 🇮🇹 Busto Arsizio, Varese, Italy

Ospedale degli Infermi; 🇮🇹 Biella, Italy

Casa di Cura di Poliambulanza, Via Bissolati 57; 🇮🇹 Brescia, Italy

Azienda Ospedaluiera Universitaria; 🇮🇹 Parma, PR, Italy

A.O. S.Salvatore; 🇮🇹 Pesaro, PS, Italy

Azienda Ospedaliera Ospedale San Carlo; 🇮🇹 Potenza, PZ, Italy

Azienda Ospedaliera; 🇮🇹 Ravenna, RA, Italy

Azienda Policlinico Umberto I; 🇮🇹 Roma, RM, Italy

AO Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

AOU Policlinico Universitario Federico II; 🇮🇹 Napoli, Italy

INT-IRCCS Fondazione G.Pascale; 🇮🇹 Napoli, Italy

Ospedale di Sondrio; 🇮🇹 Sondrio, Italy

Policlinico Universitario Campus Bio-Medico; 🇮🇹 Roma, Italy

Policlinico Universitario A.Gemelli; 🇮🇹 Roma, Italy

A.O. S.Giovanni Calabita Fatebenefratelli; 🇮🇹 Roma, Italy

A.O. Universitaria Ospedali Riuniti; 🇮🇹 Ancona, AN, Italy

Istituto Tumori Giovanni Paolo II; 🇮🇹 Bari, BA, Italy

ASDAA Bolzano; 🇮🇹 Bolzano, BZ, Italy

A.O. Humanitas Gavazzeni; 🇮🇹 Bergamo, BG, Italy

A.O. Ospedale G.Rummo; 🇮🇹 Benevento, BN, Italy

A.O. Ospedale S.Martino; 🇮🇹 Genova, GE, Italy

Azienda Ospedaliera San Paolo; 🇮🇹 Milano, MI, Italy

ULSS15 di Camposampiero/Cittadella; 🇮🇹 Camposampiero, PD, Italy

IRCCS F.S. Maugeri; 🇮🇹 Pavia, PV, Italy

A.O. S.Maria Nuova - IRCCS; 🇮🇹 Reggio Emilia, RE, Italy

A.O. Cà Foncello; 🇮🇹 Treviso, TV, Italy

A.O. Careggi-Università, Viale Pieraccini, 17; 🇮🇹 Firenze, Italy