Chemoimmunotherapy and Radiation in Pancreatic Cancer (CRIT)

Providence Health & Services

Status and phase: Completed; Phase 1

Conditions: Locally Advanced Malignant Neoplasm

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01903083

13-026A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Immunochemoradiotherapy

Experimental group

Description:

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.

Treatment:

Procedure: Pancreaticoduodenectomy

Radiation: Radiation

Drug: Gemcitabine

Drug: Tadalafil