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

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jill P. Smith; Milton S. Hershey Medical Center
• Collaborators: Milton S. Hershey Medical Center; National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Analgesics, Opioid; Enkephalin, Methionine; Enkephalins; Gemcitabine; Mitogens

Criteria

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 failure

• pregnant or nursing women

• known allergy to gemcitabine