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Chemoimmunotherapy and Radiation in Pancreatic Cancer (CRIT)

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ClinicalTrials.gov Identifier: NCT01903083
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Malignant Neoplasm Drug: Tadalafil Drug: Gemcitabine Radiation: Radiation Procedure: Pancreaticoduodenectomy Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.
Study Start Date : July 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Arm Intervention/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 resection) for eligible patients.
Drug: Tadalafil
One 2.5 mg tablet is self-administered orally by the study participant on a once daily basis.
Other Name: Cialis

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

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

Procedure: Pancreaticoduodenectomy
Surgical resection.




Primary Outcome Measures :
  1. Safety [ Time Frame: 135 Days ]
    Patients 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.


Secondary Outcome Measures :
  1. Immune Infiltration in pancreaticoduodenectomy tissue [ Time Frame: 50 Days ]
    For 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.

  2. Quantification of T cells in peripheral blood pre- and post-treatment [ Time Frame: 135 Days ]
    Patients 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903083


Locations
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United States, Oregon
Portland Providence Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Eli Lilly and Company
Investigators
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Principal Investigator: Todd Crocenzi, MD Providence Health & Services

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01903083     History of Changes
Other Study ID Numbers: 13-026A
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Providence Health & Services:
Pancreas
Pancreatic cancer
Immunotherapy
Chemotherapy
Radiation
Surgery
Pancreaticoduodenectomy

Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Tadalafil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents