Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

What Was Tested

In this phase 2 trial, researchers set out to test Met-Enkephalin (Opioid Growth Factor).

RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.

It had 1 arm (groups): metenkephalin, OGF-opioid growth factor (experimental).

The registry classes the interventions as biological.

More on the Plan

OBJECTIVES: Primary * Determine the growth inhibitory effects of opioid growth factor (\[Met\^5\]-enkephalin) in patients with advanced unresectable pancreatic cancer.

OUTLINE: This is an open-label study.

Patients receive opioid growth factor (\[Met\^5\]-enkephalin) IV over 45 minutes once weekly.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Who Took Part

Enrollment: 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of pancreatic cancer. Advanced, unresectable disease. Must have failed OR refused prior standard chemotherapy (e.g., gemcitabine or fluorouracil) for pancreatic cancer. Measurable disease by radiography. Age Over 18.

The full record lists 20 inclusion and 20 exclusion criteria; among the exclusions: no primary cns tumors or known brain metastases cardiovascular; \- congestive heart failure; symptoms of coronary artery disease.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Met-Enkephalin (Opioid Growth Factor) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2003-10 with completion listed for 2007-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Survival.

It also tracked 5 secondary outcomes, for example Response (progressive disease, stable disease, partial response, complete response), Tumor size, Quality of life, Depression and Opioid growth factor markers.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Met-Enkephalin (Opioid Growth Factor) in 25 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Met-Enkephalin (Opioid Growth Factor) compound page, all human trials.