Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether using FOLFIRINOX chemotherapy and Stereotactic Body Radiation Therapy (SBRT) prior to surgery in patients with pancreatic cancer is safe and well tolerated. This study will obtain preliminary data on the response of the cancer to this therapy by Magnetic Resonance Imaging (MRI) and by studying the cancer after it is resected surgically.

In addition, the investigators will perform biochemical studies on the tumor tissue obtained from your tissue biopsy as well as from the tumor removed by the surgeon in order to measure the effect of treatment with FOLFIRINOX and SBRT on several proteins that may be important in the behavior of pancreatic cancer cells.

The data obtained from this trial will be extremely valuable to help improve the approach to treating pancreatic cancer in the future. If you do not undergo surgery after completion of FOLFIRINOX + SBRT, the investigators will request a second biopsy of the tumor under computer tomography (CT) -guidance in order to measure the effect of treatment on your tumor.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Fluorouracil; Folfirinox; Irinotecan; Oxaliplatin; Pancrelipase

Criteria

Inclusion Criteria: Patients eligible must have:

• Histologic or cytologic diagnosis of pancreatic adenocarcinoma.

• Radiographically resectable or borderline resectable disease as reviewed by an experienced surgical oncologist at Emory.

• Age 21 years or older.

• Not received prior chemotherapy or radiation for pancreatic cancer.

• ECOG performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

• Adequate bone marrow function: absolute neutrophil count > 1,500/cmm, platelet count > 100,000/cmm.

• Understanding and be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.

Exclusion Criteria: Patients who are not eligible have

• Histologies including endocrine tumors or lymphoma of the pancreas.

• A tumor which is less than 3 mm from the duodenum as measured by either CT or MRI.

• History of central nervous system (CNS) metastases.

• Liver dysfunction, including total bilirubin > 1.5 mg/dL; aspartate transaminase (AST) and alanine amino transferase (ALT) > 5 times upper limit of the institutional normal.

• Creatinine ≥ 1.5 mg/dL.

• Albumin ≤ 2.5 g/dL.

• International Normalized Ratio (INR) ≥ 1.5 (in the absence of ongoing treatment with warfarin).

• Breast feeding.

• Serious active infection.

• Serious concurrent systemic disorders incompatible with participating in the study (at the discretion of the investigator).

• An active second primary malignancy (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.

• Clinical evidence of distant metastatic disease.