Status:
COMPLETED
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
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 ph...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00109941
Start Date
October 1 2003
End Date
April 1 2009
Last Update
September 6 2018
Active Locations (1)
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1
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850