Stereotactic Radiosurgery and Metformin in Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer

Completed · Early Phase 1

Conditions studied: Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I-III Pancreatic Cancer

In brief

This pilot clinical trial studies stereotactic radiosurgery and metformin hydrochloride in treating patients with pancreatic cancer that may be removed (borderline-resectable) or not removed by surgery. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Metformin hydrochloride, used for diabetes, may also kill cancer cells as demonstrated in laboratory studies. Giving stereotactic radiosurgery with metformin hydrochloride may kill more tumor cells.

Key facts

Study ID: NCT02153450
Run by: Case Comprehensive Cancer Center
People needed: 8
Starts: 2015-05-08
Expected to finish: 2020-06-13
Last updated by the study team: 2020-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must be able to provide written informed consent
Histologically and/or cytologically confirmed adenocarcinoma of the pancreas, clinical stage T1-4, N0-1, M0
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Hemoglobin ≥ 9.0 g/dl
Alkaline phosphatase < 3 x upper limit of normal (ULN)
Albumin > 2.5 g/dL
Absolute neutrophil count ≥ 1500/mm\^3
Platelet count ≥ 75,000/mm\^3
Total bilirubin < 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) ≤ 2.5 x institutional upper limit of normal
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
Creatinine ≤ 1.5
Borderline-resectable or locally-advanced pancreatic cancer (based upon impression of the surgical oncologist, in conjunction with radiologic consultations) as defined per the Alliance consensus :
Borderline-resectable
An interface between the primary tumor and superior mesenteric vein (SMV)/portal vein measuring 180 degrees or greater of the circumference of the vein wall
Short-segment occlusion of the SMV/portal vein but with suitable vessel proximal and distal to the obstruction to allow safe resection and reconstruction
Short-segment interface (of any degree) between the tumor and the hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction
An interface between the tumor and the SMA or celiac trunk measuring less than 180 degrees of the circumference of the artery wall
Not surgically resectable due to one or more of the following things
Patient is not a surgical candidate due to medical comorbidities and/or poor performance status
Patient elects not to undergo surgical therapy
Patient has locally-advanced pancreatic cancer based on having one of the following:
Encasement of the SMA/celiac artery (>180 degrees).
Involvement of the SMV/portal vein without options for reconstruction.
Aortic invasion or encasement.

You may not qualify if…

Evidence of gross duodenal invasion, gastric outlet obstruction
Gastrointestinal perforation or intra-abdominal abscess (< 3 months); recent (< 3 months) gastrointestinal (GI) bleeding from gastric or duodenal ulcer
Systemic collagen vascular disease including scleroderma or systemic lupus erythematosus (SLE); rheumatoid arthritis is eligible
Serious active infection requiring intravenous (IV) antibiotics
Conditions leading to inadequate gastrointestinal tract absorption as determined by the treating physician and/or investigator
Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Poorly-controlled diarrhea (> 4 loose bowel movement [BM]/day without use of anti-motility agents) within 7 days of study enrollment; patients may be reconsidered for the study if the diarrhea resolves
Comorbid conditions that, in the opinion of the investigator, would complicate safety or compliance such as known human immunodeficiency virus (HIV) or current substance abuse
Patients who are pregnant or lactating
Patients who are unwilling or unable to comply with study and/or follow-up procedures
Treatment for other carcinomas within the last two years, except cured non-melanoma skin cancer, curatively treated in-situ cervical cancer, or localized prostate cancer with stable prostate-specific antigen (PSA)
Multi-focal pancreatic lesions concerning for cancer.

Where it is running

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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