TerminatedPhase 1

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

Stopped: Problems with IRB

United States4 participantsStarted 2009-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

progression measured with CT scan

Timeframe: every 8 weeks

Trial details

NCT IDNCT00783172

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-08

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