NCT01903083

Chemoimmunotherapy and Radiation in Pancreatic Cancer

Phase I Trial of Chemoimmunotherapy and Hypofractionated Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2013-07-19
• Last updated: 2018-02-01

Locations

1 site across 1 country: United States