124 locally advanced unresectable pancreatic cancer patients will be randomized in a 1:1 ratio to receive abraxane/gemcitabine (arm A) or gemcitabine alone (arm B), as first-line chemotherapy
Conditions
Interventions
Trade Name: abraxane
Product Name: abraxane
Product Code: EU/1/07/428/001
Pharmaceutical Form: Powder and solution for solution for injection
Trade Name: Gemcitabine
Product Name: Gemcitabine
Product
Sponsors
Fondazione GISCAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous chemotherapy or radiotherapy for pancreatic cancer • CNS metastases • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore whether nab-paclitaxel in combination with gemcitabine may reduce the progression rate versus gemcitabine alone in patients with locally advanced unresectable pancreatic cancer and be worthy of further studies.;Secondary Objective: • Quality of Response • Safety profile • Progression Free Survival (PFS) Overall Survival (OS) ;Primary end point(s): Progression rate;Timepoint(s) of evaluation of this end point: progression rate will be evaluated after 3 cycles of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Quality of response - Toxicity - Progression Free Survival - Overall Survival ;Timepoint(s) of evaluation of this end point: - Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy - Toxicity will be analysed by treatment groups and CTCAE grade - Progression free survival time will be defined as the time from randomization until the date of first observed disease progression or death - Overall survival time will be defined as the time from randomization to the date of death | — |
Countries
Italy
Contacts
Public ContactData Center
Fondazione GISCAD
Outcome results
None listed