Overview

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