GAYLE JAMESON: MSN, ACNP-BC, AOCN
Associate Clinical Investigator at The HonorHealth Research Institute
Written By Julia Brabant
Clinical Trials Improve Pancreatic Cancer Survival, Response Rates
Historically, patients with advanced pancreatic cancer diagnoses have faced limited treatment options. They could undergo chemotherapy using a combination of drugs known as ABRAXANE (nab-paclitaxel), and gemcitabine, or they could do the same using a combination of drugs called FOLFIRINOX.
Known as “standard of care” options, or those widely considered by medical professionals to be the most effective forms of treatment for a particular condition, these options have offered encouraging results for pancreatic cancer patients. Yet, the survival and response rates are still nowhere close to where they need to be.
That’s where clinical trials come into play. Gayle Jameson, MSN, ACNP-BC, AOCN, is a Nurse Practitioner and Associate Clinical Investigator at the HonorHealth Research Institute, a component of the HonorHealth Medical Group. The institute performs groundbreaking scientific research and seeks to expand options and improve outcomes for patients facing a wide spectrum of conditions. A fixture at HonorHealth Research Institute in Scottsdale, Arizona since its early days in 2006, Gayle watched it grow from conducting five studies initially to more than 100, at least 13 of which currently involve treatment options for pancreatic cancer patients.
Some of those trials have participants in the early stages of pancreatic cancer, while others involve patients facing advanced pancreatic cancer diagnoses.
But how does “controlling the disease” occur? To a large extent, it happens through clinical trials. Pancreatic cancer clinical trials investigate the safety and efficacy of new treatments, or combinations of treatments, giving physicians critical information about dosage, side effects and if these treatments improve survival and response rates.
3 Phases of Clinical Trials
Most clinical trials undergo grouping into one of three “phases.”
Phase 1 Trials are those that typically involve few participants. These trials provide critical information about the safety of a particular drugs while offering insight about their effect on the human body. Phase 1 trials also help determine recommended dosage amounts of a particular treatment.
Phase 2 Trials involve more patients – potentially 100 or more – and take research a step further, focusing on the effectiveness of the drug or drugs deemed reasonably safe for use in Phase 1 trials. They also help produce critical information about disease response and survival rates.
Phase 3 Trials might have hundreds of participants and examine treatments that made it past Phase 1 and Phase 2 to compare their results against “standard of care” options currently available to patients.
If research indicates a particular treatment is (reasonably) safe, effective and better at treating a condition than other options already available, it may undergo approval for widespread use. If so, it could expand and enhance the lives of tens of thousands of current and future patients, potentially setting a new “standard of care” that supersedes the old one.
Example: The NABPLAGEM study
Many cancer clinical trials involve adding additional treatments to existing ones in an effort to improve results. Gayle served as the lead investigator over one such clinical trial, known as NABPLAGEM, and as the co-author of the associated study.
The trial examined what happened when researchers took the current standard of care option of nab-paclitaxel (ABRAXANE) plus gemcitabine and added a third component – cisplatin. The results were highly encouraging.
, that treatment regimen PLUS the third component of cisplatin added in the clinical trial caused significant tumor shrinkage in 71% of patients. Furthermore, the average length of survival for those receiving standard of care Abraxane and gemcitabine treatment was 8.5 months, whereas those who participated in the three-drug clinical trial had average survival rates of 16.4 months.
“There’s this widespread misconception that clinical trials are a last line of defense, and that’s just not the case with pancreatic cancer,” Gayle said. “There’s been so much progress in terms of developing early detection and expanding treatment options at various stages. If you have the ability to be in a study, your contributions are invaluable as far as helping us move toward a cure.”
Clinical Trials: Fact vs. Fiction
Gayle noted that there are other prevailing misconceptions about clinical trials, among them a false belief that they are available exclusively to those with deep pockets. Insurance typically covers standard of care options, she notes, and most insurance companies do cover cancer clinical trial participation.
She also dispelled concerns some potential participants have about the level of care they’d receive in a trial.
“Are there risks involved in clinical trials? Yes. Are there risks involved with standard of care treatments? Yes. But when you’re on a clinical trial, we want to know – how are you feeling every day? It’s particularly thorough care you receive, and it ensures frequent interactions with health care providers who track your health, disease response and side effects every step of the way.”
Gayle stresses that while clinical trials continue to produce promising results for pancreatic cancer patients, there’s much more work to do. “We’ve made progress, but it’s not good enough. That’s why clinical trials are helpful and necessary. Looking back on the last few years and looking where we are right now – there’s never been a more exciting time for pancreatic cancer research.”
Pancreatic Cancer Clinical Trials at HonorHealth Research Institute?
Currently, the HonorHealth Research Institute has four pancreatic clinical trial that appear promising. Three of trials cater to untreated Stage 4 pancreatic cancer patients
1. NCT03915444 – FIRST-LINE TREATMENT FOR STAGE IV ADENOCARCINOMA PANCREAS CANCER INTRAVENOUS gemcitabine + cisplatin + Abraxane.
2. NCT03410030 – FIRST-LINE TREATMENT FOR STAGE IV ADENOCARCINOMA PANCREAS CANCER INTRAVENOUS gemcitabine + Abraxane + cisplatin + ascorbic acid.
3. NCT03138720 – FIRST-LINE TREATMENT FOR LOCALLY ADVANCED/BORDERLINE RESECTABLE ADENOCARCINOMA PANCREAS CANCER INTRAVENOUS paclitaxel protein bound + gemcitabine + cisplatin + paricalcitol.
4. NCT02754726 – FIRST-LINE TREATMENT FOR STAGE IV ADENOCARCINOMA PANCREAS CANCER INTRAVENOUS nivolumab + Abraxane + paricalcitol + cisplatin + gemcitabine.
For more information about clinical trials at HonorHealth Research Institute, contact:
1 Conroy T, et al. NEJM. 2011; 364 (19): 1817-1825.
2 Von Hoff DD, et al. NEJM. 2013; 369 (18): 1691 – 1703.
3 Jameson GS, et al. JAMA Oncol. 2020; 6 (1):125-132.