Status:
COMPLETED
Chemoimmunotherapy and Radiation in Pancreatic Cancer
Lead Sponsor:
Providence Health & Services
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Locally Advanced Malignant Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Detailed Description
This study is for borderline resectable and advanced pancreatic cancer patients. Patients will receive chemotherapy with gemcitabine and immunotherapy with daily tadalafil during the first 21 days of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01903083
Start Date
July 1 2013
End Date
December 1 2017
Last Update
February 1 2018
Active Locations (1)
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1
Portland Providence Medical Center
Portland, Oregon, United States, 97213