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