Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery (OGF)

Penn State Health

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Biological: metenkephalin, OGF-opioid growth factor; Biological: opioid growth factor

Study type: Interventional

Funder types: Other

Identifiers

NCT00109941

CDR0000425404

FD-R-0002391 (Other Grant/Funding Number)

M01RR010732 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

metenkephalin, OGF-opioid growth factor

Experimental group

Description:

DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes

Treatment:

Biological: opioid growth factor

Biological: metenkephalin, OGF-opioid growth factor