Chemoimmunotherapy and Radiation in Pancreatic Cancer

NCT ID: NCT01903083

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-12-31

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.

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.

Conditions

Locally Advanced Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tadalafil

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Radiation

Intervention Type: RADIATION

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

Pancreaticoduodenectomy

Intervention Type: PROCEDURE

Surgical resection.

Interventions

Tadalafil

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

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Radiation

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

Intervention Type: RADIATION

Pancreaticoduodenectomy

Surgical resection.

Intervention Type: PROCEDURE

Other Intervention Names

Cialis; Gemzar

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Crocenzi, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

Portland Providence Medical Center

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27532020 (View on PubMed)

Other Identifiers

13-026A

Identifier Type: -

Identifier Source: org_study_id