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Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer

Phase 1
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase I Study: Electroporation Therapy With Bleomycin For The Treatment Of Pancreatic Cancer

OBJECTIVES: I. Determine the safety and surgical feasibility of electroporation therapy with
bleomycin in patients with locally advanced pancreatic cancer. II. Determine the overall and
progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive bleomycin intratumorally during laparotomy. Approximately 15
minutes after the intratumoral injection, patients receive bleomycin IV over 10 minutes.
Approximately 5 minutes after the IV injection, patients undergo electroporation therapy
comprising electrical pulses directly to the pancreas and surrounding tissues. Patients are
followed weekly for 4-6 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12-18

Inclusion Criteria

DISEASE CHARACTERISTICS: Diagnosis of adenocarcinoma of the pancreas Unresectable disease
by exploratory laparotomy Involvement of the superior mesenteric artery or occlusion of
the superior mesenteric vein-portal vein confluence No extrapancreatic metastases by
ultrasound, CT scan, or laparotomy Tumor must be accessible for direct injection of study
drug and placement of electrode array

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: AST and ALT no greater
than 3 times upper limit of normal No impaired hepatic function Renal: Creatinine no
greater than 1.5 mg/dL No impaired renal function Cardiovascular: No impaired cardiac
function Pulmonary: No compromised pulmonary function No pulmonary condition that would
potentially require the use of high FIO2 levels Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception during and for 6 months
after study No prior reaction to bleomycin No fever, infection, or other medical condition
that would preclude study Not at high risk for complications associated with abdominal

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior lifetime
cumulative dose of bleomycin greater than 400 U Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard C. Karl, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms