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

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00109941

Run by

Milton S. Hershey Medical Center

People needed

25

Starts

2003-10-01

Expected to finish

2009-04-01

Last updated by the study team

2018-09-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penn State Cancer Institute at Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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