Abraxane and Gemcitabine versus Gemcitabine alone in locally advanced unresectable pancreatic cancer.

• Conditions: 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; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002973-23-IT
• Lead Sponsor: Fondazione GISCAD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-24
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Written informed consent
•Age < 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>•Safety profile<br>•Progression Free Survival (PFS)<br> Overall Survival (OS) <br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): -Quality of response<br>-Toxicity<br>-Progression Free Survival<br>-Overall Survival<br>;Timepoint(s) of evaluation of this end point: - Response to treatment is evaluated according to the RECIST criteria at the end of chemotherapy<br>- Toxicity will be analysed by treatment groups and CTCAE grade<br>- Progression free survival time will be defined as the time from randomization until the date of first observed disease progression or death <br>- Overall survival time will be defined as the time from randomization to the date of death