D Day Minus 173 (September 17, 2009): Part 2: Trials

“Sorry for the making you wait so long.” Dr. F said as he closed the door, reviewing your chart. “But this is typical in Phase I.” Young, cute, baby-faced were the adjectives the popped in my head as soon as I saw him.  How long had he been out of med school? And did he know what he was doing?  What were we in for?  Those were the questions that popped in my head.

Dr. F put down your chart and washed his hands. He reassured us with, “But when I’m with you, you get my undivided attention. Sometimes other patients take longer.”  We responded with fake smiles and nervous laughs.

Dr. F made eye contact when he sat down. His puppy dog eyes reminded me of a little of Morgan’s. I even thought they were brown like hers. Then he said, "I'm not affiliated with the pharmaceutical company. I don’t have any stock in the company. My goal is finding cures for cancer and helping patients where standards of care have not worked to find a targeted therapy that will work.”

You and I nodded like bobbleheads and smiled - half fake/half real.

“Do you know anything about clinical trials?” Dr. F asked forcing eye contact again.

“I’m basically a guinea pig for science.” You said without batting an eye.

“No, you aren’t going to be a guinea pig.” Dr. F reassured. “You will be evaluated closely and taken off the drug if it isn't working. You will never be given anything below the standards of care.” I glanced at you, trying to find an opening for my question on trials in general.  But got preempted when you asked the question first.  Next, we leafed through a brochure on clinical trials, while Dr. F explained the four phases in clinical trials:

• Phase I is where a new drug or treatment is tested in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.  
• Phase II is where the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
• Phase III is where the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. 
• Phase IV is when studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use

“This is a Phase I trial that is just starting up, so we don’t have the exact protocol down yet. We will be figuring out the most effective dosage. You are a good candidate for the drug because you have a deficient BRAF gene. The drug is from Glaxo Smith Kline. You will have to take a pill twice a day. You will probably have to fast before you take the pill. You will need to be at MD Anderson for two days a week for the first round. A round is three weeks. After that you will get a PET scan, paid for by Glaxo Smith Kline, to see if the drug is shrinking the tumor. You will probably need to have blood draws every hour for 8 to 12 hours on day one, and several EKGs.”

Dr. F drew a funky picture of genes, cells, and cancer to show how researchers hoped the drug would inhibit, or stop, the cancer from growing. You handed me Dr. F’s artwork. And I quickly sandwich it between my printouts from the National Institutes of Health on Clinical trials and our list of questions.

“When do we start?” You asked, hope surging with the question.

"When was your last day of chemo?" Dr. F asked, paused, then added, "There’s a 28 day washout period."

 "August 28th." You said, eyes up and to the left, retrieving the date from memory. 

"So, when can he start?" I asked. My brain hurt to much to do the mental math.  I wanted to be spoon fed for once.

"Not until the week after next. I'll have you work with the scheduler to get started." Dr. F said, making eye contact again. "Any questions?"

"Nope," is what you said.  "Only a million," is what I thought.