Overview

This trial is active, not recruiting.

Condition locally advanced malignant neoplasm
Treatments tadalafil, gemcitabine, radiation, pancreaticoduodenectomy
Phase phase 1
Sponsor Providence Health & Services
Collaborator Eli Lilly and Company
Start date July 2013
End date December 2016
Trial size 10 participants
Trial identifier NCT01903083, 13-026A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Immunotherapy with oral tadalafil daily; three doses of chemotherapy with IV Gemcitabine in 21-day cycles for up to 4 cycles; three fractions of external beam radiation to the pancreas and and regional lymph nodes; pancreaticoduodenectomy (surgical resection) for eligible patients.
tadalafil Cialis
One 2.5 mg tablet is self-administered orally by the study participant on a once daily basis.
gemcitabine Gemzar
Three doses of gemcitabine (1000 mg / m^2)are given over a 21-day cycle. Patients may receive up to 4 cycles.
radiation
Patients will receive 3 doses of radiation (8-10 Gy per fraction).
pancreaticoduodenectomy
Surgical resection.

Primary Outcomes

Measure
Safety
time frame: 135 Days

Secondary Outcomes

Measure
Immune Infiltration in pancreaticoduodenectomy tissue
time frame: 50 Days
Quantification of T cells in peripheral blood pre- and post-treatment
time frame: 135 Days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.
Principal investigator Todd Crocenzi, MD
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 treatment. On study day 22, patients will receive the first of three planned doses of radiation therapy and continue daily tadalafil. Patients are then evaluated to determine if they are candidates for pancreaticoduodenectomy. Patients who are not candidates will continue daily tadalafil and receive gemcitabine chemotherapy. Patients who have surgery will resume daily tadalafil and gemcitabine chemotherapy following recovery from surgery. Patients will receive up to four cycles of gemcitabine.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Providence Health & Services.