Cancer Clinical Trials: When Running Out of Options is Not an Option, Health Matters, October 2011
Cancer treatment has come a long way over the last few decades, but better preventive measures, diagnostic tools and treatment options are always welcome. Designed to answer questions about new ways to combat cancer, clinical trials attempt to accomplish these objectives by enrolling patients into studies that explore promising options.
Patti Henry, RN, MSN, Manager of Clinical Research and Data at Salinas Valley Memorial Hospital (SVMH), says, "The National Cancer Institute and the Institute of Medicine are pushing for clinical trials to be available for every patient who has cancer. Trials are an opportunity for doctors and researchers to find better ways to prevent, treat or diagnose cancer."
Clinical trials are classified into four phases:
Phase I trials evaluate the dose and manner in which a new drug should be administered.
Phase II trials test the safety and efficacy of new drugs and usually focus on a particular type of cancer.
Phase III trials compare new treatment (usually drugs) with the current (standard) treatment and often enroll large numbers of people.
Phase IV trials investigate side-effects, risks and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials.
Cancer clinical trials offered at SVMH are phase III investigational trials conducted in cooperation with the Eastern Collaborative Oncology Group (ECOG).
"ECOG is one of the largest cooperative groups in the United States," says Peyman Haghighat, MD, SVMH cancer specialist and medical oncologist with Monterey Bay Oncology. "It's a network of physicians, researchers, academic and private institutions across the country who work together to actively enroll in these clinical trials, primarily funded by the National Cancer Institute."
While trials at SVMH address a broad range of cancers, study patients tend to be those with cancers most often seen in the community.
"We take the most common cancers," says Dr. Haghighat, "breast, lung, lymphoma and colon cancer, and provide clinical trials to patients who have run out of options."
An Institutional Review Board whose members include doctors, nurses and residents of the community must approve all cancer clinical trials at SVMH. To participate in a trial, patients should be referred by their physician, usually an oncologist, and specific guidelines must be met. Participation is voluntary so that patients may leave the trial at any time.
Help For the Underseved
SVMH collaborates with the University of California at San Francisco (UCSF), and also maintains a loose affiliation with Stanford Medical Center, Haghighat says, through which it assists the local indigent and underserved community who are historically under-enrolled in cancer clinical trials.
"The most important thing about doing trials at SVMH," says Henry, "is that it allows our patients to stay with their support systems and not have to leave the area."
Community Hospital of the Monterey Peninsula (CHOMP) also participates in phase III cancer clinical trials as well as some phase II trials.
"The general focus is on the more common cancers for our community, which are breast, lung, gastrointestinal and prostate cancer," says Grant Swanson, MD, Medical Director of the Cancer Center at CHOMP. "[They form] the lion's share of our array of clinical trials that would have the greatest applicability to the cancer we see."
Phase III trials are randomized double-blinded studies. In double-blinded trials, neither the patient nor the doctor knows whether the patient is receiving the study drug or placebo, Dr. Swanson says.
"There's this driving force to not allow any prejudices or imbalances influence the outcome," Swanson adds.
Factors such as age, sex, cancer stage and other health problems may play a role in a patient's response to a study drug.
"We want to even out the patient populations as best we can," says Swanson. "[Then] one group gets the new medication under investigation and the other does not."
Thus, if a trial patient has a response, investigators may conclude that the response is due to the study drug and not some other variable.
Like SVMH, CHOMP also maintains an affiliation with ECOG. Additionally, CHOMP has joined forces with ACTION (Alliance for Clinical Trials in Oncology). Because of these affiliations, patients can avoid travel to an academic center such as UCSF or Stanford to participate in clinical trials. Yet an alliance with these institutions is preserved.
Collaboration results in a "win-win situation," says Swanson, who explains that trial experts need access to the large database of patients treated at facilities like CHOMP.
Local Cutting-Edge Treatment
Since the majority of cancer patients are treated in the community setting, "it means that the array of clinical trials and dsitribution of new drugs are substantially higher for our patients," says Swanson. "We've got access to cutting-edge [treatment] through our local doctors. The deal, however, is that you've got to follow the rules of these trials exactly."
CHOMP formed an Institutional Review Board comprised of scientific and nonscientific volunteers from the hospital and community.
"The committee looks at a trial from the perspective of the Monterey Peninsula patient," Swanson says. "That's a layer of protection to ensure a clinical trial has been vetted by a diverse group of individuals."
Clinical trial participation can yield benefits as well as drawbacks.
In the case of a promising new treatment, patients randomly assigned to the group not receiving the treatment will not benefit from it. Additionally, unknown side-effects may occur.
On the upside, however, many patients who've received chemotherapy for breast cancer, for example, have benefitted from other patients' participation in trials and received outstanding results.
"[Many treatments] have been shown to be very effective and have become the standard of care," Dr. Haghighat says. "Clinical trials are the backbone of oncology in terms of improving survival and outcome."