Overview

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

Status:
Completed
Trial end date:
2019-01-14
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Collaborators:
Istituto Nazionale Tumori di Napoli
Unità Sperimentazioni cliniche
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
Criteria
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)

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