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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jill P. Smith, Penn State University
ClinicalTrials.gov Identifier:
NCT00109941
First received: May 3, 2005
Last updated: May 16, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biological: opioid growth factor
Biological: metenkephalin, OGF-opioid growth factor
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (progressive disease, stable disease, partial response, complete response) [ Designated as safety issue: No ]
  • Tumor size [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Depression [ Designated as safety issue: No ]
  • Opioid growth factor markers [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: October 2003
Study Completion Date: April 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: metenkephalin, OGF-opioid growth factor
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
Biological: opioid growth factor
OGF was administered in saline at 250 ug/kg intravenously over 45 minutes
Other Name: Opioid growth factor or OGF is a 5 amino acid peptide
Biological: metenkephalin, OGF-opioid growth factor
OGF given in saline iv 250 ug/kg weekly
Other Name: opioid growth factor

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109941

Locations
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Jill P. Smith
Investigators
Study Chair: Jill P. Smith, MD Milton S. Hershey Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: Jill P. Smith, Professor of Medicine, Penn State University
ClinicalTrials.gov Identifier: NCT00109941     History of Changes
Other Study ID Numbers: CDR0000425404, FD-R-0002391, M01RR010732
Study First Received: May 3, 2005
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014