Opioid Growth Factor (OGF) and Gemcitabine: Novel Treatment for Pancreatic Cancer

Stopped early · Phase 1

Conditions studied: Pancreatic Cancer

In brief

It is hypothesized that OGF biotherapy may be safely administered in combination with gemcitabine to individuals with unresectable pancreatic cancer. The study includes two aims, the first is to evaluate the safety and toxicity of the combination of OGF and gemcitabine chemotherapy. The second aim of the trial is to study the efficacy of OGF and gemcitabine when used in combination.

Key facts

Study ID: NCT00783172
Run by: Milton S. Hershey Medical Center
People needed: 4
Starts: 2009-01-01
Expected to finish: 2011-10-01
Last updated by the study team: 2018-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

unresectable and histological or cytological confirmation of adenocarcinoma of the pancreas and measurable disease by CT scan
patient has not been previously treated for pancreatic cancer

You may not qualify if…

history of cancer other than pancreatic cancer (excluding resected basal cell skin cancer or curative stage 1 cervical cancer if disease free for 5 years or more)
previous treatment with chemotherapy for pancreatic cancer
uncontrolled cardiovascular disease (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias)
suffered from myocardial infarction in preceding 6 months
poorly controlled medical conditions including: asthma, chronic obstructive pulmonary disease, diabetes, seizure disorders, known brain metastases, hepatic or renal failure
pregnant or nursing women
known allergy to gemcitabine

Where it is running

Lehigh Valley Hospital and Health Network — Allentown, Pennsylvania, United States
Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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