Around and Round on Clinical Trials
During a roundtable conversation, four cancer survivors discuss their experiences with clinical trials
This spring, four cancer survivors joined CR editor-in-chief Gwen Darien to discuss the decision-making involved in choosing whether to join a clinical trial for an advanced cancer. The topics of conversation ranged from how patients discover their clinical trial options to the financial issues that joining a study raises. Also on the table was the question of what motivated the four to participate in trials, and what would have stopped them. The participants were very honest about how they approached trials, and their discussion reflects the many variables that informed their choices.
A forthright discussion of the issues that emerged in this dialogue is critical because both patients and doctors can then understand the complex questions a person considers in deciding whether to join a clinical trial for advanced cancer. It is, perhaps, vital to improving the trial process as well.
As the roundtable discussants indicate, people join treatment trials for advanced cancers mostly in search of better results for themselves. (Issues related to clinical trials for patients with early stage cancers could differ.) Societal benefit is often a factor, too, but it is generally secondary to the person's individual needs. A decision to enroll is frequently made when a patient's desire for a good treatment option overlaps with a desire to promote good science and public benefit.
Physician views are also a critical factor in a patient's decision to join a trial, yet doctors' attitudes toward trial participation vary widely, as the roundtable illustrates. Sometimes, patients are more motivated to participate in an experimental treatment trial than physicians are to recommend one to them. Other times, doctors readily suggest the trial option. Additionally, consider that a doctor may be both a health care provider and a clinical investigator. In this case, what impact does the clinical trial option have on the relationship between a physician and a patient?
No one knows in advance if the experimental arm of a randomized clinical trial will prove to be as good as, better than or worse than the standard of care. While a clinical trial would never take place if initial data didn't support the study's hypothesis, the study wouldn't (and couldn't ethically) proceed if doctors already knew which treatment was best. But with this uncertainty, how do you decide what is really the right choice for the patient?
Discussing the thorny issues in the clinical trials process can be uncomfortable. Some are particularly challenging: How do we address the gaps between those who have the resources to join a trial without regard to financial, geographic and information barriers, and those who lack such resources? Does this further perpetuate health disparities?
We hope that this roundtable among trial participants provides a critical and open starting point for a dialogue about cancer clinical trials. A roundtable in a future issue of CR will look at clinical trials from the perspective of health care providers.
ANNETTE BOCCABELLO, 50, of Boston, was diagnosed with stage II breast cancer in January 2005 and with advanced breast cancer in October 2005. After her second diagnosis, Boccabello entered a phase III clinical trial that was testing Femara (letrozole) and temsirolimus versus Femara alone. This second drug was already on the market for kidney cancer, and researchers wanted to see if it would work with Femara against advanced breast cancer. Boccabello joined the trial in October 2005; it ended in early April due to high toxicity and marginal results in the Femara-plus-temsirolimus patient group. Boccabello was among the group of patients randomly assigned to take Femara with a placebo, not temsirolimus.
HOLLISTER MOORE, 60, of Philadelphia, was diagnosed with stage I clear cell kidney cancer in 1994. Doctors removed his right kidney and saw no remaining evidence of the disease. About eight years later, doctors discovered and surgically removed a tumor blocking his small intestine and another on his pancreas. Both were metastases from the kidney cancer. In 2004, very small tumors appeared on his lungs. In November 2004, he entered a phase II clinical trial in which he took Avastin (bevacizumab), Tarceva (erlotinib) and Gleevec (imatinib mesylate).
SEAN PATRICK, 55, who lives just outside Carbondale, Colo., was diagnosed in 1997 with stage IIIC of a rare form of ovarian cancer, called micropapillary serous carcinoma. Her cancer appeared to be resistant to traditional chemotherapy. In 1999, two years after her diagnosis, she entered a phase III trial conducted by a doctor at single health care facility. The study was investigating an experimental therapy for solid tumors that involved filtering the patient's blood and boosting the immune system. Patrick has also had several surgeries for her cancer.
BRAD SILVER, 36, of Shaker Heights, Ohio, was diagnosed with grade IV glioblastoma multiforme, a type of brain cancer, in March 2003. He had surgery, chemotherapy and radiation before starting a phase I clinical trial in October 2003. The trial was testing the safety of a therapy called dendritic cell vaccination. The researchers took a type of white blood cells, called dendritic cells, from Silver and combined them with protein from his tumor in a lab. The idea was that these dendritic cells might learn to recognize his cancer. Then, the researchers injected the cells back into Silver's body, hoping that the therapy might stimulate his immune system to fight the tumor.