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OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study

Phase 1
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

OGF & Gemcitabine: Novel Treatment for Pancreatic Cancer Phase I, A Safety and Toxicity Study

Pancreatic cancer is the 4th leading cause of cancer-related deaths in the United States
with a median survival of 3-6 months and a five-year survival rate of 1% making it the worse
of all gastrointestinal malignancies. The reason for the poor prognosis is related to
failure to diagnose this cancer in early stages and the unresponsiveness of pancreatic
cancer to conventional chemotherapy and radiation therapy. Gemcitabine has become the
standard of care in treatment of advanced pancreatic cancer; however, the mean survival with
gemcitabine is reported at only 5.6 months. Our research team has discovered a novel
biotherapy called Opioid Growth Factor (OGF) that inhibits growth of pancreatic cancer in
vitro, in animals, and in human subjects. A Phase 1 study with OGF has been completed and
the maximum tolerated dose, safety and toxicity evaluated. Currently a Phase 2 trial is in
progress to study the efficacy of OGF monotherapy in those who have not responded to
standard treatment. Recent experiments from our basic science laboratories indicate a marked
additive benefit in cancer inhibition when OGF is combined with gemcitabine. Additionally,
animals receiving the combination regime were healthier than those treated with gemcitabine
alone suggesting perhaps a protective effect of OGF to chemotherapy toxicity. It is
hypothesized that OGF may be safely administered in combination with gemcitabine to
individuals with unresectable pancreatic cancer. In order to test this hypothesis 22
eligible naïve patients with pancreatic cancer will be prospectively treated with standard
doses of gemcitabine. Concomitantly, OGF will be administered weekly starting at 150 μg/kg
and increasing to the Maximum tolerated dose of 250 μg/kg in order to determine the
following specific aims: 1) evaluate the safety and toxicity of the combination of OGF
biotherapy and gemcitabine; 2) determine whether the combination therapy alters the
pharmacokinetics of either agent; and 3) study the efficacy of combination therapy on tumor
size, patient survival, and time to progression of disease. The long-term goal of our
research team involves translation of novel discoveries from the basic science laboratory
into clinical practice with the ultimate goal of improving survival of patients with this
devastating disease.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- pregnant or nursing women

- known allergy to gemcitabine

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression measured with CT scan

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Jill P Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State University


United States: Food and Drug Administration

Study ID:

PSU-20978 and 35686EP



Start Date:

January 2009

Completion Date:

October 2011

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • pancreatic cancer
  • cancer
  • Opioid Growth Factor
  • OGF
  • gemcitabine
  • chemotherapy
  • Pancreatic Neoplasms



Penn State Hershey Medical Center Hershey, Pennsylvania  17033
Lehigh Valley Hospital and Health Network Allentown, Pennsylvania  18103