Clinical Trials

If you, or someone you love, has been diagnosed with colorectal cancer that has been treated with a chemotherapy regimen containing oxaliplatin, and a regimen containing irinotecan, and are now no longer responding to chemotherapy or you fear that you or your loved one will become refractory to chemotherapy in the near future, you should consult with your oncologist about your further treatment options.

Your oncologist may advise that you are a candidate for the FDA-approved drugs called Stivarga® (Regorafenib) and Lonsurf® (TAS-103). If so, you may also be a candidate for experimental treatments being offered as part of a clinical trial. In some cases, these clinical trial options are mutually exclusive in that you may no longer be a candidate for some clinical trials if you elect to be treated with Stivarga and Lonsurf. Therefore, this information on clinical trials is provided to assist you in evaluating all your options. The clinical trial now open at Banner-MD Anderson Medical Center in Phoenix, AZ is a Phase IIb clinical trial of an experimental cancer vaccine immunotherapy drug for metastatic colorectal cancer. Read below to learn more about clinical trials.

WHAT IS A CLINICAL TRIAL?

Clinical trials are an important part of medical research. Clinical trials are human research studies which provide evidence regarding the safety and effectiveness of experimental new drugs. The FDA relies on data from clinical trials to determine whether new medicines are suitable for wide-spread use in the clinic. Clinical trials in oncology are generally aimed at improving survival and quality of life for people with cancer.

POTENTIAL BENEFITS

  • You get early access to promising new experimental drugs before they are available to othersYou usually receive more medical care and are more closely watched and followed by your doctors.
  • The experimental new therapy may work for you.
  • Even if the experimental therapy does not benefit you, your participation in the trial may serve to benefit other cancer patients.
  • Many late stage cancer patients feel like the medical community gives up on them, clinical trial participation provides continued hope for those with a fighting spirit

POTENTIAL RISKS

Participating in clinical trials may entail certain risks, both known and unknown:

  • The new experimental treatment may not be better than, or even as good as, any standard treatments that are available and may actually make your disease worse;.
  • New treatments may have side effects that doctors do not expect or that may be worse than those of the available standard treatment. Some side effects may be so new and unexpected that doctors will not know how to diagnosis or treat them. The side effects could be severe and even lethal.
  • You usually are required to make more visits to the doctor in a clinical trial than if you were receiving standard treatments, which may involve extra expenses, such as travel and child care costs.
  • You may need extra lab tests or procedures, such as biopsies which may be uncomfortable, time consuming and increase risk of side effects.
  • Even if a new treatment has benefit in some patients, it may not work for you.
  • Health insurance may not cover all patient care costs that are incurred in a clinical trial.

TYPES OF CLINICAL TRIAL DESIGNS

There are many types of clinical trial designs. Some clinical trial designs randomize patients to a control arm. Patients in a control arm of a clinical trial do not receive the experimental drug, they may instead receive standard therapy or could even receive a placebo. In other clinical trial designs, patients may receive the experimental drug, but a dose levels too low to provide any effect or provide an effect less potent than other doses.

CLINICAL TRIAL PHASES

There are several phases of clinical trials that occur before an experimental treatment can be approved. Each phase is designed to answer certain questions. As such, there are different factors related to each trial phase to take into consideration when choosing a trial that might be right for you.

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Phase I Trials

Phase I trials are conducted to determine safety of an experimental new drug. Many phase I trials represent the first time that a particular drug is being tested in patients.. Phase I trials are small and typically enroll 5 to 30 patients.

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Phase II Trials

Phase II trials are larger trials to test for signs of clinical efficacy of a treatment, usually in a more defined cohort of patients, such as patients with a specific cancer type. Phase II trials are larger than phase I trials and may enroll up to 100 patients.

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Phase I/II Trials

A Phase I/II clinical trial is common in cancer indications. This type of trial combines the determination of safety and efficacy in a single trial. Phase I/II studies are intermediate size, usually enrolling up to 50 patients.

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Phase IIa and Phase IIb Trials

Phase IIa and Phase IIb clinical trials are exploratory trials that provide proof-of-concept. Phase IIa trials focus on how a drug works (mechanism), while Phase IIb studies focus on finding the optimal dosing and/or frequency of dosing.

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Phase III Trials

Phase III trials include large numbers of patients, often hundreds to several thousands, and are designed to test if a new treatment is better than the current standard of care. Often, phase III trials are randomized, which means that some patients will receive the experimental treatment and others, in the control group, will not. Regardless, all patients will receive the standard of care, whether they are in the treatment or control group.