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

NCT ID: NCT00109941

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-04-30

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 patients with advanced pancreatic cancer that cannot be removed by surgery.

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 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metenkephalin, OGF-opioid growth factor

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

Group Type: EXPERIMENTAL

opioid growth factor

Intervention Type: BIOLOGICAL

OGF was administered in saline at 250 ug/kg intravenously over 45 minutes

metenkephalin, OGF-opioid growth factor

Intervention Type: BIOLOGICAL

OGF given in saline iv 250 ug/kg weekly

Interventions

opioid growth factor

OGF was administered in saline at 250 ug/kg intravenously over 45 minutes

Intervention Type: BIOLOGICAL

metenkephalin, OGF-opioid growth factor

OGF given in saline iv 250 ug/kg weekly

Intervention Type: BIOLOGICAL

Other Intervention Names

Opioid growth factor or OGF is a 5 amino acid peptide; opioid growth factor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill P. Smith, MD

Role: STUDY_CHAIR

Milton S. Hershey Medical Center

Locations

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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. doi: 10.1097/00001813-200403000-00003.

Reference Type: BACKGROUND

PMID: 15014352 (View on PubMed)

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. doi: 10.2147/oajct.s8270.

Reference Type: RESULT

PMID: 20890374 (View on PubMed)

Other Identifiers

FD-R-0002391

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

M01RR010732

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000425404

Identifier Type: -

Identifier Source: org_study_id