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Clinical Trial Record

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Chemoimmunotherapy and Radiation in Pancreatic Cancer

2013-07

2017-12

2017-12

10

Study Overview

Chemoimmunotherapy and Radiation in Pancreatic Cancer

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.

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.

  • Locally Advanced Malignant Neoplasm
  • DRUG: Tadalafil
  • DRUG: Gemcitabine
  • RADIATION: Radiation
  • PROCEDURE: Pancreaticoduodenectomy
  • 13-026A

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2013-07-02  

N/A  

2018-01-31  

2013-07-16  

N/A  

2018-02-01  

2013-07-19  

N/A  

2018-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Immunochemoradiotherapy

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 resect

DRUG: Tadalafil

  • One 2.5 mg tablet is self-administered orally by the study participant on a once daily basis.

DRUG: Gemcitabine

  • Three doses of gemcitabine (1000 mg / m^2)are given over a 21-day cycle. Patients may receive up to 4 cycles.

RADIATION: Radiation

  • Patients will receive 3 doses of radiation (8-10 Gy per fraction).

PROCEDURE: Pancreaticoduodenectomy

  • Surgical resection.
Primary Outcome MeasuresMeasure DescriptionTime Frame
SafetyPatients will return be seen in the clinic 8 times over the first 50 days for an evaluation of adverse events and toxicities before being evaluated for surgery. Patients who are not candidates for surgery will be seen in clinic 10 more times over the next 85 days for safety evaluations, and patients who have surgery will be seen 10 times over the 85 days following recovery from surgery for safety evaluations.135 Days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Immune Infiltration in pancreaticoduodenectomy tissueFor surgery patients, formalin fixed and paraffin-embedded tumor tissue obtained during surgery will be sectioned and immunohistology performed to determine the tumor inflammatory micro-environment and the degree of macrophage and T cell inflammation.50 Days
Quantification of T cells in peripheral blood pre- and post-treatmentPatients will provide a pre-treatment blood sample and 4 blood samples over 135 days to evaluate the influence of the study treatment on immune parameters. For patients who have surgery, the time period will be longer depending on their recovery time. Post-treatment long term follow up will occur every 12 weeks (+/- 2 weeks) beyond post-recovery date (PRD) 85 for 6 visits. Blood will be collected for immune monitoring at each visit.135 Days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Eli Lilly and Company
  • PRINCIPAL_INVESTIGATOR: Todd Crocenzi, MD, Providence Health & Services

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Crocenzi T, Cottam B, Newell P, Wolf RF, Hansen PD, Hammill C, Solhjem MC, To YY, Greathouse A, Tormoen G, Jutric Z, Young K, Bahjat KS, Gough MJ, Crittenden MR. A hypofractionated radiation regimen avoids the lymphopenia associated with neoadjuvant chemoradiation therapy of borderline resectable and locally advanced pancreatic adenocarcinoma. J Immunother Cancer. 2016 Aug 16;4:45. doi: 10.1186/s40425-016-0149-6. eCollection 2016.
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