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Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II

Phase 2
18 Years
80 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II



- Determine the growth inhibitory effects of opioid growth factor ([Met^5]-enkephalin) in
patients with advanced unresectable pancreatic cancer.


- Determine the pharmacokinetics of this drug in these patients.

- Determine the quality of life of patients treated with this drug.

- Determine the pain control, depression, and nutritional status of patients treated with
this drug.

OUTLINE: This is an open-label study.

Patients receive opioid growth factor ([Met^5]-enkephalin) IV over 45 minutes once weekly.
Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 weeks during study treatment, and at the
completion of study treatment.

Patients are followed weekly for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria

Inclusion criteria

- Diagnosis of pancreatic cancer

- Advanced, unresectable disease

- Must have failed OR refused prior standard chemotherapy (e.g., gemcitabine or
fluorouracil) for pancreatic cancer

- Measurable disease by radiography

- Age Over 18

- Performance status Karnofsky 50-100%

- Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- WBC ≥ 3,500/mm^3

- Hemoglobin ≥ 8.5 g/dL

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 4.0 mg/dL (stents allowed)

- PT or INR ≤ 2 seconds over control OR ≤ 1.8 (unless on warfarin) renal & metabolic

- BUN ≤ 30 mg/dL (hydrated)

- Creatinine ≤ 2.0 mg/dL

- Sodium ≥ 130 mmol/L

- Potassium ≥ 3.2 mmol/L

- Glucose 60-300 mg/dL

- Pulse 60-110 beats/minute

- Systolic blood pressure 90-170 mm Hg

Exclusion Criteria

- No primary CNS tumors or known brain metastases Cardiovascular

- - congestive heart failure

- symptoms of coronary artery disease

- cardiac arrhythmia

- poorly controlled hypertension

- myocardial infarction within the past year

- abnormal EKG

- asthma

- hronic obstructive pulmonary disease

- pregnant or nursing

- Fertile patients must use effective contraception

- serious infection requiring antibiotics within the past 2 weeks

- poorly controlled diabetes

- seizure disorders

- fever > 37.8° C

- other malignancy within the past 5 years

- concurrent chemotherapy

- concurrent oral steroids

- concurrent radiotherapy

- Surgery within 4 weeks

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Jill P. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

April 2009

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850