IRB Number
|
#20978
|
| Description |
Evaluate the safety and toxicity
of the combination of OGF biotherapy and gemcitabine chemotherapy in
patients with advanced pancreatic cancer. Examine the role of OGF given with
gemcitabine on efficacy of tumor size, patient survival, and time to
progression in subjects with advanced pancreatic cancer. |
| What is expected of me? |
Physicals, Blood work, and
Questionnaires are involved. Intravenous treatments with OGF and Gemzar. |
| Inclusion Criteria |
Patients must have unresectable and histological or cytologic confirmation
of adenocarcinoma of the pancreas and measurable disease. Patients must
be treatment naïve. |
| Exclusion Criteria |
Patients with a 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). Patients with poorly controlled
medical conditions including asthma, chronic obstructive pulmonary
disease, diabetes, seizure disorders, known brain metastases, hepatic or
renal failure and pregnant or nursing women are not eligible. Patients
with a known allergy to gemcitabine are not eligible. |
| Length of Study |
Two years |
| Study Location |
Penn State Hershey Medical Center,
Hershey, PA
General Clinical Research Center, H4500 |
| Investigator Information |
Jill P. Smith, M.D.
Gastroenterology & Hepatology |
| To obtain more information about this study please contact: |
Sandra Bingaman, R.N.
(717) 531-8108
sbingaman@psu.edu |
