NCT02043730

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Pancreatic Cancer Stage II

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel and Gemcitabine	Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle
DRUG	Gemcitabine	gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-03-01
• Completion: 2019-01-14
• First posted: 2014-01-23
• Last updated: 2019-10-09

Locations

39 sites across 1 country: Italy