Chemoimmunotherapy and Radiation in Pancreatic Cancer

NCT01903083 | Completed Phase 1

• 1 other identifier: 13-026A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Malignant Neoplasm

Keywords

Pancreas; Pancreatic cancer; Immunotherapy; Chemotherapy; Radiation; Surgery; Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  135 Days

Secondary Outcomes (2)

• Immune Infiltration in pancreaticoduodenectomy tissue

  50 Days

• Quantification of T cells in peripheral blood pre- and post-treatment

  135 Days

Study Arms (1)

Immunochemoradiotherapy

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.

Drug: Tadalafil; Drug: Gemcitabine; Radiation: Radiation; Procedure: Pancreaticoduodenectomy

Interventions

Tadalafil DRUG

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

Also known as: Cialis

Immunochemoradiotherapy

Gemcitabine DRUG

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

Also known as: Gemzar

Immunochemoradiotherapy

Radiation RADIATION

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

Immunochemoradiotherapy

Pancreaticoduodenectomy PROCEDURE

Surgical resection.

Immunochemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Providence Health & Services: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

Related Publications (1)

• 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.

  PMID: 27532020 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Tadalafil; Gemcitabine; Radiation; Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Physical Phenomena; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Todd Crocenzi, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 19, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)