Learn About Phase I Trials

 

What is a Phase I cancer clinical trial?

Phase I cancer clinical trials are the earliest phase of study treatment in people and may involve agents not yet available commercially or drugs already FDA-approved but given in a new way or in new combinations. Unique to these early-phase trials is the need to determine the appropriate dose of the treatment. This stage of the study is called “dose escalation.” Starting at doses far lower than those found to be safe in animals, the doses are slowly increased while safety is vigilantly monitored. Once the maximum tolerated dose has been determined, the study moves to the "expansion" phase where a larger number of patients are treated to further assess the safety of that dose. Although effectiveness of the treatment is certainly of interest in a Phase I study, later-phase studies are done to determine efficacy and compare the new treatment to standard treatments for the disease.

Why participate in a cancer clinical trial?

Cancer treatments used today require rigorous testing in clinical trials prior to their formal approval. Participation in clinical trials is the sole means of making therapeutic advances to improve the lives of patients and identify potential cures.

What are the risks and benefits of joining a phase I cancer clinical trial?

All cancer clinical trials require the patient understand the risk, benefits, trial process and alternative treatment options. This is called the informed consent process. A discussion with the physician and study coordinator will review the consent document and address questions. Signing the consent signifies you understands the trial and wishes to participant. However you can withdraw for the study at any time.

Patients enrolled in phase I trials are extensively monitored and may require additional visits and tests. While all treatment will be administered at our National Cancer Institute (NCI) designated UC Davis Comprehensive Cancer Center by the Phase I team, your local oncologist will still be involved in your overall care. Once you finish your clinical trial participation, all of your care will be transferred back to your oncologist.

Will my insurance cover the treatment?

The experimental treatment is provided at no cost to you. However routine tests and procedures that you would normally have if you were receiving a standard treatment will be billed to your insurance company. These routine tests will be performed at a location where your insurance will cover them at the lowest possible out of pocket expense.

What should I expect during my initial consultation with the doctor?

During a scheduled appointment in the Phase I clinic, the oncologist will explain the clinical trial that you might be eligible for and inform you of possible risks, benefits, the treatment and your rights in regard to clinical research participation. After a thorough explanation, you will be asked if you consent to participate in the study and, if so, to sign a consent form. You will likely meet the study coordinator responsible for the study at that time. From there, the study coordinator will arrange for screening procedures such as tests and scans to confirm your eligibility. Only then can you be enrolled on the clinical trial. At that point, an authorization coordinator will assist the study coordinator in developing a treatment plan calendar detailing where the tests or procedures will be performed.

Can I keep my regular oncologist?

Yes, of course. Because SCOPE is a partnership between Dignity Health, Kaiser Permanente, Sierra Hematology Oncology, Sutter Health and UC Davis Health, your referring oncologist remains your primary care provider. However, all study-related treatment must be given at the UC Davis Comprehensive Cancer Center. In many cases, care has to be coordinated between UC Davis and your referring oncologist's office throughout the study period due to insurance requirements. All of your care will resume with your referring oncologist once the study treatment is completed.

How long does it take to enroll in a cancer clinical trial?

Generally it takes 1-2 weeks to begin study treatment although it can take longer under particular circumstances. The first step is to have a consult with a phase I physician and determine if there is a clinical trial for you. If so, and you agree to participate by signing the consent form, you will enter screening. This involves a series of tests that must be performed to make sure it is safe for you to receive the treatment.

What if I don’t qualify for a trial?

Your information will be added to our list for consideration of future studies. The Phase I program continuously opens new trials. We will communicate with you and your doctor if a suitable new trial becomes available.

 

Do you have questions regarding Phase I Cancer Clinical Trials? Please fill out the form below and we’ll respond to you within one (1) business day. Please be advised we cannot provide medical advice via this forum.