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UA Director of Clinical Trials elaborates on biliary tract cancer research

Courtesy Rachna Shroff
Headshot of the University of Arizona section chief of GI Medical Oncology.

Courtesy Rachna Shroff

Headshot of the University of Arizona section chief of GI Medical Oncology.

Dr. Rachna Shroff is the chief of the section of gastrointestinal (GI) medical oncology at the UA Cancer Center. 

Shroff has been conducting research in improving the survival of patients with biliary tract cancers. In a media release, Shroff says that her research involves adding a third drug, nab-paclitaxel, to the existing two drug treatment of gemcitabine and cisplatin for biliary tract cancers.

The Daily Wildcat sat down with Dr. Shroff to learn more about her and her research. 

Daily Wildcat: What got you interested in the medical profession?

Rachna Shroff: My interest in medicine probably started back when I was in high school, and I was actually in high school here in Tucson, Arizona. I grew up with a mother who was a physician and a father who was a biochemist here at the UA. I did some research here at the UA Cancer Center and it was cancer-based research, and I think that sparked my initial interest in science, medicine and more specifically oncology. 

DW: What drew you to your interest in working in oncology, specifically, biliary and pancreatic cancers? 

RS: When I was doing my medical oncology fellowship at the Anderson Cancer Center in Houston, Texas, I actually started the fellowship with the intention of treating hematological malignancies, but I ended up doing a rotation in GI medical oncology and found a fantastic mentor who happened to be an expert in the treatment of pancreatic cancer. It’s a devastating disease with a dismal prognosis and it just really needs a lot of minds working on it to improve outcomes for patients. That’s what really drew me to it, my interest in clinical research and my desire to improve outcomes for pancreas cancer. 

So, then I kind of switched tracts and ended up doing GI oncology, and then more specifically when I started working on faculty at Anderson Cancer Center, I ended up starting to see and treat patients with biliary cancer. It was a similar thing where there were very limited therapeutic options and a lot of room for clinical research, and, frankly, because it was a rare cancer with not a lot of people working in that space. I wanted to be able to help improve therapeutic outcomes for these patients and it was at a place where we were seeing a high volume of these patients. It was really easy to build a research program because there were patients who it would directly impact to put on clinical trials. 

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DW: What brought you to work at the UA? 

RS: I was recruited here to be the section chief of GI oncology with the intention of building the clinical research program in GI cancers here. There’s a fantastic team here already. There are three other GI oncologists, and I was brought in to round out the team and help us all work together and bring cutting edge trials and bring that to patients here in Arizona. Specifically, because of my interest in writing and designing clinical trials. The hope would be that I could increase the number of trials here in hopes that there could be trials for every patient that walks through the door. 

DW: In your media release about phase II of your research, you mentioned that many people thought it would be too difficult to conduct clinical trials for these biliary cancers. Why do you think they thought this?

RS: Well it’s a rare disease by the technical definition. We only see about seven to ten thousand cases a year of cholangiocarcinoma, which is one type of biliary cancer, and about another 7,000 cases of gallbladder cancer. When you compare that to something like colon cancer, which is about 100,000 cases a year, from a pharmaceutical company perspective I can understand that it would seem very difficult to start and complete a clinical trial in this disease because it is just a rare malignancy and it might be hard to find patients to put on trials. Our phase II study kind of proved that wrong. It accrued in rapid-fire time. We actually had to hold accrual so that our research team could keep up with the pace in the sense that patients were wanting to go on this trial. It was clearly not a case compared to what pharmaceutical companies were worried about. 

DW: What inspired you to go against the idea of clinical trials being too difficult for this cancer? 

RS: Stubbornness. Ha, I’m just kidding. I think it was really, like I said, I was seeing these patients every day in clinic. When I first started treating this disease, I had no novel treatments or trials to offer them and that just wasn’t good enough. The only way we are going to push the needle forwards in cancer is by thinking outside the box and testing new treatments. So, knowing I had no clinical trials for them motivated me to try to write one and think of one that would be something anyone sitting in my clinical could be considered for because that’s what they need. They need hope, and hope comes in the form of novel treatments and doctors who are passionate about finding those new treatments for the patients. It was that alone, being in clinic every day and seeing patients that reminded me of why we are doing what we are doing and why we need to keep pushing. 

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DW: How did you come up with the idea of adding the third drug, nab-paclitaxel, to the pre-existing standard treatment? 

RS: It’s a drug that is already FDA approved in a couple different cancers, including pancreas cancer, and what we know with pancreas cancer is that it is notoriously a chemo-resistant disease because there’s this, what we call, a stroma that basically protects the tumor and prevents chemo-therapy from accessing the cancer. Biliary cancers are very similar. They have a protective barrier that leads to chemo-resistance. Nab-paclitaxel is thought to dissolve away that stoma in pancreas cancer, so I thought that perhaps it could work the same in biliary cancers and that’s why I suggested adding it to what was already the standard combination.

DW: After the success of the trial’s phase II, how is phase III going?

RS: It’s a national study and I’m the national principle investigator. It’s funded by the NCI, the National Cancer Institute, and it’s launched across what’s called the National Clinical Trial Network [NCTN], which is a number of different, what we call, cooperative groups, so these are oncology groups that all work together and can be community based for academic centers. For instance, the UA Cancer Center is a part of SWOG, which is the Southwest Oncology Group. So, I started this trial through SWOG, so any institution that is a part of SWOG institution can be enrolled to the study. But since we opened it across the entire NCTN, basically any cooperative group participating institute can open this study. 

So, it is a randomized phase III study, patients are randomized. For every two patients that go on the gemcitabine, cisplatin and nab-paclitaxel, one person gets the standard of care treatment, or just gemcitabine and cisplatin. Two hundred sixty-eight patients are supposed to be enrolled — that’s the planned number — and we are looking to improve overall survival. We are comparing the two arms and checking to see if the three-drug combination is improving overall survival or how long patients are living with this disease compared to the standard of care treatment. It has already accrued 44 out of the 286 patients, which is fantastic because it has only been open for about seven months. 

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