Expired Study
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Hershey, Pennsylvania 17033


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00109941


Primary Contact:

Study Chair
Jill P. Smith, MD
Milton S. Hershey Medical Center


Backup Contact:

N/A


Location Contact:

Hershey, Pennsylvania 17033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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