1. La nanomedicina in oncologia: presente e futuro
Alessandro Bittoni
Scuola di Dottorato di Ricerca- Clinica di Oncologia Medica
AOU Ospedali Riuniti - Università Politecnica delle Marche
Ancona
La nanomedicina in oncologia: presente e futuro
GAP (Gemcitabine Abraxane Pancreas)Trial
Bari, 27 Marzo 2015

2. Background and Rationale
Study Design and Objectives
Study Populations
Enrollment Status
Patients’ Characteristics

3. Background and Rationale
About 25-30% of pancreatic cancer pts present with locally advanced disease (LAPC)
Chemotherapy followed by chemoradiation is an accepted strategy in this setting
Gemcitabine + nab-paclitaxel was shown to be superior in terms of RR, PFS and OS to gemcitabine in stage IV pts
No data in LAPC

4. Study Design and Objectives
Phase II, randomized, open-label, multicenter study
ARM A
nab-paclitaxel + gemcitabine
3 cycles
ALL
Capecitabine + RT
5 weeks
Locally advanced pancreatic cancer R
ARM B
gemcitabine
3 cycles
If PD
Second Line Chemotherapy
Arm A: nab-paclitaxel 125 mg/mq + gemcitabine 1000 mg/mq
days q28
Arm B: gemcitabine 1000 mg/mq

5. Study Design and Objectives
Primary Endpoint
Progression rate after 3 months
Secondary Endpoint
RR, toxicity, PFS, OS
124 pts required for final analysis
40% vs 20% PR, one-tailored alpha= 0.05, 80% power
After 109 events the study will have 80% powe to detect 0.62 HR and 61% to detect 0.69 HR

6. Main Inclusion Criteria
Study populations
Main Inclusion Criteria
Written informed consent
Age < 75 years
Histologically/cytologically confirmed locally advanced, unresectable PC
At least 1 measureable lesion (RECIST 1.1)
ECOG 0-1
Life expectancy of at least 3 months
Adequate marrow, liver and renal function

7. Main Exclusion Criteria
Study populations
Main 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
Previous or concurrent malignancies

8. Enrollment started on 07 February 2014
Enrollment status
Enrollment started on 07 February 2014
Enrollment will stop on April 2016
9 patients enrolled
aggiornato al 30 Settembre 2014

9. Enrollment status

10. Enrollment status

11. Patients Characteristics

12. Safety
3 SAE reported

13. Grazie per l’attenzione!