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

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer Stage II

Treatments: Drug: Gemcitabine; Drug: Nab-paclitaxel and Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02043730

2013-002973-23

Details and patient eligibility

About

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.

Full 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

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

nab-paclitaxel and gemcitabine

Experimental group

Description:

ARM A: 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

Treatment:

Drug: Nab-paclitaxel and Gemcitabine

Drug: Gemcitabine

Gemcitabine

Active Comparator group

Description:

ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Treatment:

Drug: Gemcitabine