Clinical Trial Basics

Eligibility Criteria

There are requirements that must be met before you can enter a clinical trial — common inclusion criteria and common exclusion criteria.

Common Inclusion Criteria

Common inclusion criteria include cancer status, health and performance status, measureable disease, and a requirement for a tumor biopsy.

Cancer Status

• Whether you are in remission or have progressive disease

• Whether your cancer has responded to treatment with platinum or has not responded to treatment.

• Occasionally, trials are for patients with a specific histological type of ovarian cancer (i.e., high grade serous, low grade serous, mucinous, clear cell, endometrioid, carcinosarcoma).

Health and Performance Status

To be a participant in the trial, your blood cell counts and blood chemistry tests will have to meet certain criteria so that your body can tolerate the drugs being administered in the trial.

Measurable Disease

Depending on the type of drug being tested and the stage and purpose of the trial, your cancer will have to be measureable by imaging procedures, such as CT or PET/CT scans. Even if your CA125 is on the rise, without measurable disease, you will not be eligible for some clinical trials. For these trials, your response to the drug treatment will be monitored by scans which will track the size of specific tumors in your body.

Tumor Biopsy For Biomarker Evaluation

You may need to provide a tumor biopsy specimen and/or blood sample in some instances. For example, if a trial is measuring biomarkers or genomic changes in correlation to drug response or trying to identify new biomarkers or genomic changes that will be predictive of response your tumor or blood may need to be tested.

Common Exclusion Criteria

One of the most common exclusion criteria is prior treatment. It is one that many women don’t think about ahead of time and as a result, they are not eligible for participation in the trial.

Prior Treatment

For some clinical trials, you are not eligible if you have had too many prior treatments (this can often be 3 or less) or have already had a drug that is being given in combination with the one that is being tested in the trial. This latter point is important because it includes commonly used chemotherapy drugs like gemcitabine (Gemzar) and pegylated liposomal doxorubicin (Doxil), as well as bevacizumab (Avastin). The patients who receive only the chemotherapy drug (considered the placebo group) are in the control arm of such trials and their responses are compared to patients who receive BOTH the chemotherapy drug AND the new agent. In order to more easily compare the two groups of patients, the trial only enrolls those women who have not previously taken the chemotherapy drug. So, it is important to know which trial agents make sense for you before you take these standard chemotherapy drugs. Your Clearity Tumor Blueprint can help you and your doctor make those decisions.

Clinical Trial Phases

Phase I Trial 

First-time test of intervention in a small group of people (20-100) to evaluate safety, determine appropriate dosage and identify side effects.

Phase II Trial 

Intervention given to a larger group (100-300) to evaluate effectiveness and safety.

Phase III Trial

Intervention given to large groups (1,000-3,000) to confirm effectiveness, monitor side effects, compare to other treatments and collect information that will allow it to be used safely.

Phase IV Trial

Post marketing studies determine additional information including risks, benefits and optimal use of an intervention.