Precision Promise was designed by the Pancreatic Cancer Action Network (PanCAN) to accelerate new treatment options for pancreatic cancer. Weill Cornell Medicine is one of 15 premier cancer treatment institutions from across the United States to be selected as a Clinical Trial Consortium site for this trial.

The purpose of this study is to find out about the safety and efficacy of a number of various drugs for the treatment of metastatic pancreatic cancer. Participants will be randomly assigned to one of the following research arms:

Gemcitabine plus nab-paclitaxel

Gemcitabine plus nab-paclitaxel chemotherapy will be administered intravenously via a central venous catheter. If you do not already have a central venous catheter in place when you start the study, your study doctor will ensure that one is placed before your treatment is to begin or shortly after the start of your treatment. This drug combination is currently considered a standard of care treatment for metastatic pancreatic cancer. This treatment is approved by the United States Food and Drug Administration (FDA)for the treatment of metastatic pancreatic cancer.

Your study doctor will talk with you about what will happen during your study visits.

FOLFIRINOX

FOLFIRINOX will be administered intravenously via a central venous catheter. If you do not already have a central venous catheter in place when you start the study, your study doctor will ensure that one is placed before your treatment is to begin or shortly after the start of your treatment. This drug consists of folinic acid, fluorouracil, irinotecan, and oxaliplatin. This drug combination is currently considered a standard of care treatment for metastatic pancreatic cancer. This treatment is approved by the FDA in the United States for the treatment of metastatic pancreatic cancer.

Your study doctor will talk with you about what will happen during your study visits.

SM-88 with methoxsalen, phenytoin, and sirolimus 

SM-88 will be given along with methoxsalen, phenytoin, and sirolimus which are commercially available on the market. The drugs together work by using unstable molecules in the body to kill cancer cells. The combination of SM-88 with methoxsalen, phenytoin, and sirolimus is also considered investigational. The term “investigational” refers to any drug or device that is being tested and is not approved by the FDA in the United States for your disease. This means SM-88 with methoxsalen, phenytoin, and sirolimus can be used only in research.

Your study doctor will talk with you about what will happen during your study visits.

Optional Actigraphy (sub-study)

The purpose of this sub-study is to explore a way to identify patients who may have disease progression. This part of the study aims to find a reliable marker that would enable proactive treatment changes that could improve both quality of life and treatment effectiveness.

 It is noted that in patients with pancreatic cancer, the decrease in daily movement occurs at a remarkably early stage of the disease, before any tumor can be detected. This sub-study will reliably and accurately monitor daily activity patterns over time using a device worn on the body. This method of collecting daily movement data is called actigraphy. The actigraph device helps in estimating an individual’s duration, intensity, and total quantity of physical activity.

The actigraph device used in this sub-study is a Fitbit. You must possess a Fitbit-compatible smartphone to be able to participate in this sub-study. Fitbit is an activity tracker worn on your wrist.

Your participation is voluntary. Whether or not you decide to take part in the optional research sub-study will not affect your participation in the main study and it will have no effect on your medical care. You can still participate in the main study if you choose to not participate in this sub-study.