A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

This is an interventional treatment trial for Adenocarcinoma Read More

Inclusion Criteria:

• Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
• Patients with the presence of at least one measurable lesion.
• Male or non-pregnant and non-lactating female of age >18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
• Must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who will be considered for surgery are ineligible.
• Patient who have had any prior chemotherapy within 5 years of enrollment.
• Patient who have had radiotherapy for pancreatic cancer.
• Age ≥ 76 years
• Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
• Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
• Patient who has known brain metastases.
• Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan.
• Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patient who has serious medical risk factors involving any of the major organ systems.
• Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
• Pregnant or breast feeding.
• Patient is unwilling or unable to comply with study procedures
• Patient with clinically significant wound.