Clinical trial NCT00109941: Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Official title: Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2005-05-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: Response (progressive disease, stable disease, partial response, complete response)
measure: Tumor size
measure: Quality of life
measure: Depression
measure: Opioid growth factor markers
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jill P. Smith, MD
role: STUDY_CHAIR
References:
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. doi: 10.1097/00001813-200403000-00003.
citation: 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.