Pancreatic Cancer Research

Clinical trialPhase 2Completed

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

Outcome
Finished, no results posted
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
January 2014
Expected end
14 January 2019
Enrollment
124 participants
Sites
39
Primary outcomes
Progression Rate
Sponsor
Other
Results posted
No
Last update
9 October 2019

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Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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