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

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