Colorado veterans with cancer will have better access to clinical trials thanks to a unique collaboration that dramatically expands their treatment options.
Though the Denver Veterans Administration has been a member institution of the University of Colorado Cancer Center since the Center’s inception in 1988, this December the partners took another important step, expanding cancer clinical trials collaborations to offer early-stage trials of new drugs at the VA.
Clinical trials allow cancer patients to participate in cutting-edge research, often with promising new medications still under development — medications they would otherwise not be able to access. Many of these trials are particularly important options for cancer patients whose tumors are hard to treat with standard therapies or for whom all other standard treatments have failed.
“When I came here almost four years ago, it struck me that while we were offering cancer clinical trials for people from out of state, with all kinds of insurance, and working with the Kaiser Permanente Colorado system to offer their patients our trials, we weren’t offering those same options to our veterans,” says Antonio Jimeno, MD, PhD, director of the Head and Neck Cancer Medical Oncology Program at the CU Cancer Center.
While the Denver VA has access to many cancer clinical trials, some of the most exciting studies incorporating new drugs still under early investigation were not available to their patients. It didn’t seem fair, so Jimeno and others in his group including fellow Daniel Bowles, MD, decided to do something about it.
“The VA will be moving to the Anschutz Medical Campus in the next few years, but our team and our veteran-patients felt we should expand the clinical trials relationship much earlier than that. Patients should not have to wait,” Bowles says.
“In addition, the VA has historically been an engaged and valuable contributor to cancer research. In fact, one of the most relevant clinical trials in head and neck cancer came from the VA 20 years ago,” Jimeno says.
In this case, the collaboration included clinicians, research and administrative personnel from both the CU Cancer Center and the VA, which is a member of the CU Cancer Center consortium.
“We received an enthusiastic response from everybody,” Jimeno says. “Meetings went well, the atmosphere was extremely collegial, and we made the clinical trials partnership between the VA and the CU Cancer Center happen within six months.”
With the partnership framework in place, the question was what trial to open first. Jimeno and his group had the answer to that question, too: a trial of PX-866, a drug that stops signals through a pathway that is a known offender in cancer: PI-3-kinase.
Cells can become cancerous when the signals that tell them when to divide and die malfunction. The PI-3-kinase signaling pathway, which tells cells to divide, is known to cause many types of cancer if it becomes faulty by telling them to proliferate out of control–the definition of cancerous.
Four years of preclinical lab work and early clinical trials, mostly by Jimeno and Bowles, showed that the drug PX-866 stops signals through this pathway.
“We went from the lab to first-in-human phase I trials, and then to combination trials all here in Denver,” Jimeno says.
In fact, at the 2011 conference of the American Association for Cancer Research, the National Cancer Institute, and the European Organization for Research and Treatment of Cancer, Jimeno presented findings from the CU Cancer Center’s two phase I trials of the drug. Both trials were combinations of PX-866 with known chemotherapeutic drugs.
In one case, PX-866 was combined with docetaxel to treat non-small cell lung cancer or head and neck cancer. In this safety trial, 75 percent of patients (21 of 28) saw their disease stabilize.
The second phase I trial of PX-866 was in combination with cetuximab. Of eight patients treated for incurable colorectal or head and neck cancer, three stabilized and four actually showed a partial response.
“Everyone at the conference was very enthusiastic about the results,” Jimeno says. And this enthusiasm has resulted in two, multi-site phase II trials that Jimeno will lead. Those two studies are being conducted nationwide in over 20 centers each. And unlike the phase I trials, the Colorado home of these trials won’t be the CU Cancer Center alone.
“We had decided to partner with the VA because it was the right thing to do and because it aligned with our mission,” Jimeno says. “Now, last week, we treated our first Colorado veteran with PX-866 and cetuximab.” The second trial, aimed at head and neck cancer and lung cancer, will soon open at the VA.
Continuation of Denver VA clinical trials will be overseen by Daniel Bowles, who will take a joint appointment at the VA and the University of Colorado School of Medicine in the summer of 2012, and Dr. Christiane Thienelt, a VA staff oncologist, and by Catherine Klein, MD, Chief of Medical Oncology at the Denver VA.
“We are very excited about the prospect of offering these research trials to our cancer patients. Our veterans are enthusiastic about participating in research and are quite selfless in offering themselves to help move forward the body of knowledge that will shape tomorrow’s cancer care, “ says Klein. “The Denver VA is the flagship hospital for the Eastern Colorado Health Care System and serves not just veterans in Colorado, but also Wyoming, parts of eastern Kansas and Montana. We expect these patients to benefit as well.”
Most importantly, these trials bring cutting-edge cancer therapies to Colorado veterans who wouldn’t have been eligible for them last holiday season.
“This has been an extraordinary example of how, when people set out to do the right thing, no barriers can stop us. A huge team of people from both sides including clinical coordinators, nurses, administrators, and docs worked relentlessly to make it happen. We’re all really, really proud of this,” Jimeno says.