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

Pancreatic Cancer Stage II Clinical Trial

Official title: A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Pancreatic Cancer Stage II
• Pancreatic Neoplasms

• NCT number: NCT02043730
• Study type: Interventional
• Source: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Completion date: January 14, 2019