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

Pancreatic Cancer Clinical Trial

— OGF  

Official title:

Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109941
• Other study ID #: CDR0000425404
• Secondary ID: FD-R-0002391M01R
• Status: Completed
• Phase: Phase 2
• Start date: October 2003
• Est. completion date: April 2009

Study information

• Verified date: March 2013
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2009
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• opioid growth factor
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
• metenkephalin, OGF-opioid growth factor
OGF given in saline iv 250 ug/kg weekly

Locations

Country	Name	City	State
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Smith JP, Bingaman SI, Mauger DT, Harvey HH, Demers LM, Zagon IS. Opioid growth factor improves clinical benefit and survival in patients with advanced pancreatic cancer. Open Access J Clin Trials. 2010 Mar 1;2010(2):37-48. — View Citation

Smith JP, Conter RL, Bingaman SI, Harvey HA, Mauger DT, Ahmad M, Demers LM, Stanley WB, McLaughlin PJ, Zagon IS. Treatment of advanced pancreatic cancer with opioid growth factor: phase I. Anticancer Drugs. 2004 Mar;15(3):203-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival
Secondary	Response (progressive disease, stable disease, partial response, complete response)
Secondary	Tumor size
Secondary	Quality of life
Secondary	Depression
Secondary	Opioid growth factor markers