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OHC Clinical Trials: Colorectal Cancer

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March 4, 2015


March is Colorectal Cancer Month. And it comes with good news. Small to big strides are being made every day in determining new, more effective treatment options. We can say this with first-hand experience and authority, as OHC is a regional leader in conducting these highly advanced clinical trial studies.

Unfortunately, there’s good reason why OHC needs to take a clinical trial leadership role. The American Cancer Society estimates that there will be 93,090 new cases of colon cancer and 39,610 new cases of rectal cancer in 2015 in the United States, and an estimated 49,700 deaths. It is the second leaning cause of cancer-related deaths in men and women combined.

Yet, the death rate has dropped in the last 20 years, due to better screening methods and improved treatment. Most of which come out of clinical trials. Here are OHC colorectal studies you might be interested in sharing with others.

OHC Colorectal Clinical Trials

According to Lynnetta Hart, Clinical Research Director for the OHC Research Department, there are currently three clinical trials for colorectal cancer at OHC. The first trial, which opened November 2014, studies a drug called Avastin 2.0 (or R05520985). Avastin 2.0 is a new version of the drug Avastin.

This study is for newly diagnosed patients with colorectal cancer. Patients involved in this trial also have metastatic disease, or cancer that has moved to other parts of the body.

The study is used alongside full standard treatment. It is a double-blinded study, meaning neither the doctor nor the patient know if they’re getting Avastin or Avastin 2.0. The drugs are administered intravenously in a treatment suite at OHC.

The second trial involves patients with metastatic, refractory disease. Refractory disease means that the patient has already had at least one type of treatment for colorectal cancer and their condition worsened.

This study is blinded. Patients involved in this study receive Regorafenib as standard treatment, plus or minus the study drug called Ruxolitinib. Both of these medications are given orally. The goal of this drug is to increase how long patients survive. The study opened in December 2014 and is expected to close in October 2015.

According to Brittany Hagen, Clinical Research Manager at OHC, cachexia occurs when a patient with cancer has lost a lot of muscle mass. Which leads us to our third colorectal trial here at OHC.

According to Brittany, few patients are diagnosed with cachexia because the physicians at OHC do everything they can to prevent cachexia from happening.

This trial studies the drug MABP1, which is the only drug used. Candidates of this trial are usually not good candidates for other types of treatment. “This treatment,” says Brittany, “is for patients who haven’t seen success with other drugs.”

All three studies are expected to go on for a year and a half to two years. The length of trials tends to vary and it is always based on enrollment.

Colon Colorectal Cancer Infographic ACS OHCThe Goal of Clinical Trials

The goal for clinical trials is two-fold: the pharmaceutical company sponsoring the study wants its drug to be FDA approved, in the hopes that it is better than what’s currently available. And it provides another treatment option for patients.

“Of course,” says Brittany, “our doctors and our patients here want to see if it will work for them.”

The primary endpoint of any trial is overall survival. “We’re trying to better our treatment for future patients,” adds Lynnetta. “Our patients are lucky enough to participate and have access to these new drugs, and help shape the future of new treatment.”

Clinical Trials Can Be Your First Line of Treatment

“I think there is misconception among many people that trials are people’s last option and they’re really not,” says Brittany. “There are many trials that are the first line (of treatment).”

When a patient is first diagnosed with colorectal cancer, they may have four or five different treatment options to choose. If those first options don’t work well for them, it is a plus to have trial drugs in the repertoire of treatment options.

“Everything that is standard treatment right now, at one point was a trial,” adds Lynnetta.

How To Get Started On A Trial

According to Brittany, if a patient wanted to get involved with a trial, they should start by asking their physician if there’s a trial they may qualify for.

Physicians have access to all trials and utilize their research nurse. According to Lynnetta, the role of a research nurse is to pre-screen new patients to see if they qualify for a trial. Current patients are also pre-screened if their therapy progresses, or if they relapse after being stable.

Screening patients for trials is extremely important. “Just because a person might qualify for a study, doesn’t mean it’s appropriate,” notes Lynnetta.

Among other things, a patient’s performance status, or the patient’s current condition, plays a big part in whether or not a patient is appropriate for a trial. A patient’s comorbidities are also considered in screening for a trial. Comorbidities can include other illnesses like heart disease or diabetes. Whether or not the comorbidity is well controlled is also considered in the screening process.

In a recent study, only 6% of colorectal cancer patients were aware of a related clinical trial.

In a recent study, only 6% of colorectal cancer patients were aware of a related clinical trial.

Each study has different requirements for participants.

“Probably the one thing that I think every trial requires is that the patient has to be willing to abide by the rules of the study,” says Brittany. This includes coming to treatment when it’s required, divulging their complete medical history including other medications they take, and a willingness to be open and honest with the OHC’s medical team.

Not every OHC location hosts trials, all OHC patients have access to them. If a patient is receiving treatment at an OHC office that does not host its own trials, they can talk to their physician about moving to another OHC location. “Just because they’re at a particular OHC office that doesn’t do research, doesn’t mean they don’t have access to an OHC trial,” says Lynnetta.

Where Are OHC Trials Offered?

Six OHC locations offer research trials: Anderson, Blue Ash, Eden Park, Fairfield, Kenwood, and West in Ohio. “We try to offer research close to home for everyone,” says Lynnetta.

Don’t Wait…Join An OHC Trial Today

To quote a phrase OHC Head of Research David Waterhouse, MD, MPH, often uses (from the Sarah Cannon Research Institute), “Participating in clinical trials is the first step to fighting cancer, not the last.”

To find out more about our clinical trials, visit our Current Trials page and download a list of our current clinical trials.


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