Pancreatic Cancer
Conditions
Keywords
recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Brief summary
RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: Primary * Determine the growth inhibitory effects of opioid growth factor (\[Met\^5\]-enkephalin) in patients with advanced unresectable pancreatic cancer. Secondary * 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.
Interventions
BIOLOGICALopioid growth factor
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
BIOLOGICALmetenkephalin, OGF-opioid growth factor
OGF given in saline iv 250 ug/kg weekly
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response (progressive disease, stable disease, partial response, complete response) | — |
| Tumor size | — |
| Quality of life | — |
| Depression | — |
| Opioid growth factor markers | — |
Countries
United States
Outcome results
None listed