Clinical Trials
at the Eastern Connecticut Hematology
and Oncology Center
Susan Johnson, Pharm D
Eastern CT Hematology and Oncology Associates
(ECHO) is a unique community-based private practice
offering a broad spectrum of cancer trials to our
patients. As of January 2018 we have 29 active clinical
trials. In 2016, 79 patients participated in clinical trials,
approximately 11% of our patients compared to the
national average of 2-3%. In addition 80 patients were
enrolled in IELCAP, a clinical trial for early screening
for lung cancer in smokers and former smokers. Most
of our clinical trials are phase II and phase III studies.
Phase II trials evaluate new drugs which have completed
phase I toxicity and dose finding studies. Phase II trials
are evaluating potential efficacy and toxicity of the
drug at a predetermined dose, and usually involve less
than 100 patients for untreatable or refractory cancers.
Phase III trials compare a new drug with a standard
treatment or placebo and may involve several hundred
or several thousand patients. The ECHO center has
newly participated in phase I trials as of 2017. These
trials require intensive pharmokinetic testing, linking
blood levels of drug to efficacy and toxicity in addition
to determining the spectrum of toxicity and maximal
tolerated dose. ECHO also participates in phase IV
trials, studying long-term safety and efficacy after FDA
approval and marketing.
The selection of clinical trials at ECHO is based on
our cancer population. The most frequent cancers are
breast, lung, prostate, colorectal and bladder.
According to the Backus Hospital Tumor
Registry, there were a total 648 new cancer
cases in 2016, 120 breast, 98 lung, 79
prostate, 48 colorectal cancer, and 51 bladder.
O PEN J O UR NAL • W I NT E R 2 0 18
We have fostered excellent relationships with the
scientific liaisons throughout the pharmaceutical
industry and I am kept appraised of promising drugs in
the research pipeline. We also have access to National
Institute of Health clinical trials through the NRG
(National Surgical Adjuvant Breast Project, Radiation
Therapy Oncology Group, Gynecology Oncology
Group) cooperative trials, formerly separate research
groups since the 1970s. ECHO and Backus Hospital
have been active members of all the major cooperative
groups (NRG and ECOG) since the 1980s. And now
we have access to Memorial Sloan-Kettering Cancer
Center clinical trials through the Hartford Healthcare
Alliance.
Every new oncology consult is presented at the Backus
Hospital Multidisciplinary Tumor Board and screened
for participation in a research trial. If the oncologist
and collaborating physicians feel the patient may
benefit from participation in the clinical trial, the initial
step is a rigorous screening for eligibility. This may
include additional radiologic studies and laboratory
studies to assess organ function and susceptibility
to potential toxicities of the investigational drug. If
eligible for a research trial, a lengthy discussion is
conducted with the patient and family regarding the
potential risks and benefits of the trial and signing of
the consent form after due process. The patient is then
assigned a research nurse coordinator who follows the
patient throughout the course of the study. The nurse
coordinator is essential for first line of communication
and support for the patient and works intimately with
the infusion nurses, advanced nurse practitioners and
physicians, and the data managers, insuring accuracy
of the treatment administration and data reporting.
continued on page 30
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Other essential members of the research team include
data managers responsible for computerized reporting
forms, drug entering and dispensing, collection and
processing of laboratory specimens, scheduling of
radiologic tests, and the overall regulatory processes.
Sound clinical research depends on proper functioning
of every member in the research team.
In addition to the pharmacy industry trials, cooperative
group trials, and MSKCC alliance trials, ECHO works
vigorously to identify new treatments based on genomic
alternations and proteomic testing of tumor samples,
currently popularized as “personalized medicine”
or “molecular medicine”. These treatments apply
mostly for patients whose cancers have progressed
after conventional therapies. An interesting data set
was presented by Gene Charles Soria, MD, PhD,
and Professor of Medicine at the Institut Gustave
Roussy. 1035 patients with advanced stage cancer
progressing after first-line therapy were then treated
with conventional second-line therapy or targeted
therapy based on genomic analysis. The progression-
free survival was superior with targeted therapy in
33% of patients, 2 with complete responses, 20 with
partial responses, 100 with stable disease, and 33 with
progressive disease. The overall survival for patients
was 11.9 months. Single patient INDs are formulated
with a pharmaceutical company and the FDA to create
an individualized protocol for a specific patient. This is
time consuming and labor intensive, but may offer the
possibility of expanded therapeutic options.
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Expanded access or compassionate plea therapies are
assuming a greater role in the treatment of refractory
cancers since the introduction of immune checkpoint
inhibitors. These drugs prevent the antitumor immune
response and may have more general therapeutic
applicability. Immunotherapies (checkpoint inhibitors,
tumor vaccines, CAR-T and other forms of adoptive
immunotherapy) are rapidly expanding with many
active clinical trials. ECHO has partnered with all of
the research centers in the northeast to connect our
patients to the most relevant clinical research trial.
Some of our patients do not have the physical or
financial means to travel to a major research center and
treatment can often be provided on expanded access or
compassionate plea programs as described above.
A unique clinical trial sponsored by ECHO is
incorporating the CANscript bioassay to determine
tumor sensitivity to chemotherapy or immunotherapy.
Tumor tissue is tested in a patented bioassay,
potentially guiding therapy and avoiding ineffective
and potentially toxic treatments.
After decades of painfully slow progress on the
therapeutic front, clinical oncology is reaping the
benefits of basic science groundwork established by
the Human Genome Project, as well as the strides
made in tumor immunology over the past two decades,
and progressing rapidly with personalized molecular
medicine and more generalized immunotherapies. Cures
for many cancers are within reach, and the clinical
research program at ECHO is well positioned to deliver
these new promising therapies to our community. g
O P E N JO URNAL • W I NTE R 2018