Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.
- Conditions
- Pancreatic Cancer Stage II
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
- 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)
- 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
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 deathOverall 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. CÃ Foncello
🇮🇹Treviso, TV, Italy
A.O. Careggi-Università , Viale Pieraccini, 17
🇮🇹Firenze, Italy