Opioid Growth Factor (OGF) and Gemcitabine: Novel Treatment for Pancreatic Cancer (NCT00783172) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.