Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 9/8/2018 |
| Start Date: | October 2003 |
| End Date: | April 2009 |
Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
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.
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.
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.
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.
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
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