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

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.

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

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