Chemoimmunotherapy and Radiation in Pancreatic Cancer

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to evaluate the safety of combination treatment that includes chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborator: Eli Lilly and Company
• Treatments: Gemcitabine; Tadalafil

Criteria

Inclusion Criteria:

• Pancreatic adenocarcinoma

• Locally advanced unresectable disease, or borderline resectable disease

• ECOG (Eastern Cooperative Oncology Group)Performance Status 0 or 1

• Ability to provide consent and comply with study protocol

• Women of child-bearing potential must have a negative pregnancy test and avoid pregnancy during the study

Exclusion Criteria:

• Age < 18

• History of other malignancy in previous 2 years except carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer

• Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation to the target field

• Clinically active autoimmune disease or active infection

• History of heart attack within 90 days or stroke within 6 months, hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (NYHA >= Class 2 in last 6 months), unstable angina, or angina during sexual activity

• Use of nitrates or nitroglycerin

• History of hereditary degenerative retinal disorders including retinitis pigmentosa

• Chronic systemic corticosteroid use at supra-physiologic doses

• Use of recreational drugs called 'poppers' like amyl nitrite and butyl nitrite

• Blood test results (neutrophils < 1000 /uL (microliter); hemoglobin < 9 gm /dL; platelet count < 1000 cells / uL; significant coagulopathy; significant liver or renal dysfunction