How Did You Get Into the CO-1686 Clinical Trials?

When people ask me, “How did you get into the CO-1686 Clinical Trials?,” I am always tempted to claim that I had a stroke of genius, telling me to do it, enter the trial, get treated, avail myself of free medicine for life, and have fun – if I live to tell the tale. But I can’t say those things. The truth of the matter is, I got into the CO-1686 trial because it fell on my lap. My Onc in Albuquerque, who happens to have lung cancer, referred me to his own Onc in Colorado, who happens to be the Big Kahuna of the trial in University of Colorado in Denver Cancer Hospital. This occurred at the time my good friend Tarceva was beginning to fail me. My Onc said, “If he’s good enough for me, he should be good enough for you.” I liked that. Henceforth his Onc became to me my Onc’s Onc.

Anybody can try to get into any of the clinical trials that abound in the world of cancer or other disease for that matter. They are open to anybody who qualifies.

I first heard of the term clinical trials when my husband, who successfully beat prostate cancer, was talking about a new drug, which turned out to be Crizotinib. The other prolific googler in the household, he tried to explain to me the clinical trials. At that time I had no cancer, so my interest on the topic was zero. But I was polite. All the time he was talking about clinical trials, I gazed at him lovingly the way Nancy Reagan did to her Ronnie, a smile plastered on my lips but thinking, what the hell is he talking about? What a difference a cancer diagnosis and participation in a trial make! Now the phrase “clinical trial” is music to my ears. It sends me! Okay, some people have simple pleasures.

Trying for participation in a clinical trial is easy. Trying is one thing, getting accepted is another. The requirements or qualifications are very strict, not negotiable at all. Even if the CO-1686 trial fell on my lap, if I did not meet its requirements, I might as well had never heard of it. So, the important thing is to know what the trials are for, and go for them.

So where does one find trials? Here’s one resource:

http://www.nih.gov/health/clinicaltrials/findingatrial.htm

One can also look at Universities that have Cancer Centers or Hospitals. Here’s the one where I am participating:

https://www.uchealth.org/Pages/clinical-trials.aspx

Got the drift? Awesome!

Looking Forward to CO-1686 Scans After 6 Weeks

I’m so excited! I just can’t hide it!

Remember those two lines from the song? That’s exactly how I feel these days as I await June 2nd, the day the Clovis Trial folks will scan my body to see what it looks like inside after being bombarded with 63,000 mg of the trial drug over a period of six weeks. Of course, like everybody else who has experienced going through “before” and “after” scans, I face uncertainty. Maybe the drug worked, maybe it didn’t. I’m the self-proclaimed grand guru of optimists so I like to think it worked, based on what I’ve read, but until I know from the scans, I don’t know. That is just the fact of the matter. This fact sends some people to pray, cry, vent, etc. Any manner of dealing with it is good. Everybody is different. Whatever works.

Each time I am due for an “after” scan, I pull out my file of previous scans and read them for knowledge and entertainment of some form. I do have a morbid sense of humor. As we all know, knowledge is power. The more one knows, the more empowered one feels. Looking at something related to the cause of fear, is like taking the bull by the horns, so to speak, and staring at it eyeball to eyeball. I might have considered becoming a professional bullfighter when I was younger, but thunder thighs don’t look sexy in those tight “toreador” pants.

Ever since I was a little girl, I have always faced things that scare me, head on, to get rid of the fear. My fear of allergy for example. My family, then living in absolute poverty, ate what we could afford in the worst slums where sanitation was unheard of. What did not kill us strengthened our immune systems. We ate fish, oysters, and shrimp that abounded in the Pacific Ocean and the Philippine seas and rivers. No, they were not of the variety for Bouillabaisse, Oysters Rockefeller and Shrimp Scampi. They were the tiny ones that the indigent folk, like my family at the time, shoved in their faces by the handful. I was allergic to them. After eating them, it was pretty scary. I’d get itchy rash and asthma, my body would transform into one hive, I’d pass out and wake up with my eyes swollen shut. My mother decreed that I stop eating shellfish. I protested. I was allergic to most seafood, we could not afford meat, what was I supposed to eat with my rice? A maverick before the age of eight, I secretly disobeyed my mother. After recovering from each allergy event, I’d eat a little oyster or shrimp at a time, suffered allergies all over again, ate them again and again until they did not bother me anymore. I became immune. Soon, I could eat shellfish in front of my family, a triumphant smile plastered across my face and without fear of allergies or scolding. Of course, the self-immunization process could have killed me, too! To this day, I enjoy seafoods fearlessly.

Back to the scans. Reading my past scans again and again provide distraction. It keeps reminding me of the knowledge gained, like the “intact fat plane” mentioned in my first scan, the one that led to the biopsy, and eventually to the diagnosis. The report indicated that “a 3cm x 3cm mass (my main tumor, which Tarceva smacked down to 1cm x 2cm then quit) is located at the bottom of the lower left lung. An intact fat plane lies between the thoracic aorta and the mass.” I googled “intact fat plane” like an obsessed witch. Happily retired, I had nothing else to do. My research made me realize it’s important to have some fat in our innards. An intact fat plane prevents the cancerous tumor from encroaching on the nearby organs. I love any justification for eating with abandon! Now, when I read posts about trying to lose weight or gaining weight while with cancer, I just have to put my two cents in about the intact fat plane.

So between now and June 2nd, I’ll be a raving “radiologist” of sorts!

Tarceva Diva says, “CO-1686, Yes!”

May 12, 2014 – May 13, 2014

For this trip, my son, my only biological child, served as my driver. At age 40, he is half his stepfather’s age. This awesome young man is still in the middle of navigating life as a fine artist, architect, entrepreneur, husband to a lawyer, and father to an eight-year-old boy genius who is the favorite grandchild of Abi (moi!). On this particular trip, my son was simply Mother’s caregiver. His stepfather and I would have stretched this trip to a four-day/three-night get-away, but because my son is still part of the working class that rightly supports older people like me, he did it the fast and furious way. He hauled me into Denver and hauled me out of Denver at a dizzying pace. For the most part he stayed within the speed limit. We’re talking pace here. From the time he picked me up at my house to the time he delivered me back to my house, it took sixteen hours. Yes 16 exciting hours. It was a good thing we were not co-riders on a Harley, or the growth of my newly sprouted post-Tarceva hair would have been stunted.

May 13, 2014

Thank goodness for a few precious moments of calm in between the marathon driving. I am one patient who is filled with calm and contentment during appointments at the trial clinic. What’s wrong with me? Between the drive in and drive out, there was enough time for a good night sleep and about four hours of clinical trial business.

As usual the day at the clinic started with the blood draw after at least eight hours of fasting. My husband and I have always come at the lab at 7:00a.m. when the waiting room officially opens. This time my son and I came at 8:00. Something about younger people of the working class needing more sleep. Several patients were already waiting. When my turn came, a middle-aged bald Black woman appeared and called my name. Together, we went to a cubicle in the blood draw room. Unlike in the early hours, I noticed half a dozen medical technician / patient pairings in open cubicles in various stages of bloodletting, in silence. When my med tech looked down to start our session, I realized she wasn’t bald. Her dark brown kinky one millimeter long hair just blended with the color of her scalp. I decided to pierce the quiet of the room. I struck a conversation with her.

“Is this what you have always wanted to do in your life?” I asked.

She roared in laughter. I made a mistake. She was unstoppable. She talked about trying to be a nurse first, then she joined the service – the army. She served in the service with her husband in Germany. She was in the service until her retirement. After hearing the phrase “in the service” many times, I became so patriotic that I felt like paying my income tax in advance. Soon three tablespoons of blood and a specimen cup of urine were again separated from me. Time to move on.

My son and I went to the hospital cafeteria to break our fasts. Then we moseyed on to the serious clinical trial stuff and the moment of truth: the visit with the Good Doctor C, my Onc’s Onc. First the intake nurse took my weight. Same five pounds overweight. No gain, no loss. Then he took my blood pressure. No frightening numbers. Bohhhhrrrring!

“All the blood readings are good,” Doctor C assured me as his eyes scanned the numbers on the computer monitor. Then he zeroed in on the glucose numbers. “Almost the same as last time. It even went down one point. Great.” He turned around to face me. I was sitting on the examination table, my feet in Z-Coil shoes dangling.

“This is amazing!” he exclaimed. “Three people taking the same medication and three different results.” He talked about one trial participant, a woman whose glucose count rose 350 points and a man whose glucose reading went up to 900 and had to be sent to the hospital. “And here you are, your glucose even went down one point.”

“Congratulations!” My son interjected. “You have been in the placebo group!”

We burst into laughter, then the three non-doctors shut up when Doctor C started talking again.

“One Japanese woman participant’s glucose is not affected either. I don’t mean to lump all Asians together, but it must have something to do with the way different races process the Clovis drug. Asians seem to process it better.”

His explanation was music to my ears; excellent words to cap Cycle 1 of the trial.

After the Doc’s mandatory stethoscope motions on me, the Trial Coordinator, my son, and I picked up my fresh three-week supply of pills: 6 pills at 150-mg each, two times a day. Since this was Day 1 of Cycle 2, I had to do the little drama of my taking the first six pills in front of an audience consisting of my trial handler and my son. One pill, one gulp of water to shove the pill down my throat, six times. After the show, my son and I ate lunch at Smash Burgers while waiting for two hours to see if the drug would send my heart into turmoil. The EKG proved it did not. Cycle 2 has begun!

As I write this, I say, Success so far! And in spite of the furious short trip, I still had this long story to tell!

Next event: First scans after six weeks.

14 Days CO-1686, 17 Days 0 Tarceva

May 5, 2014

My husband steered the wheel gently as he negotiated the sharp curve heading to the Colorado state line. It was the perfect place for me to look at the the visor mirror. No, not to admire the scenic winding road behind me but to study my face after 17 days of zero Tarceva circulating in my system. I saw a facial skin that had become clear and glowing and smooth to the touch just like the skin throughout my body. After 20 months on Tarceva, I had already forgotten about natural body oils that make the fingers slide on the arms and legs. I thought, I can enter the Miss Senior Bernalillo County pageant now and give all those little old ladies a run for their money. But not so fast! The full head of hair has yet to grow on my scalp. Maybe it will take 17 weeks, not 17 days. Bummer! My stomach growled, reminding me of yet another awesome happening in a post-Tarceva existence. The days of the “squirt” diarrhea are long gone. There’s no more need to strategize the shortest path to the nearest restroom. I don’t mean to malign Tarceva. After all, for 20 months, it was a comfort drug to me, much like a warm bottle of milk formula is to a baby. I could not imagine life without Tarceva. But now, since it started failing me, I’m so into the CO-1686 trial drug. In the two weeks that I’d been on it, it hadn’t given me an iota of a side effect. Nothing. Zilch. Nada. No skin dryness, no diarrhea, no loss of appetite, no fatigue, no weight loss, no post-nasal drip. Absolute nothing. Who knows, the drug might be doing nothing for me either, but that’s a concern for another day. I’m just hoping that if it will ever have any side effects, it would one that transforms me into a senior babe with big hair.

May 6, 2014

After fasting for 12 hours, accompanied by my loving husband/caregiver, I went to the lab early to get my blood drawn. Early was important; I must feed my face immediately afterwards. Hunger is not one of my favorite sensations. This day would be my first check up after 225,000 mg of the CO-1686 trial drug carpet-bombed my system for 14 days. My Onc’s Onc, Trial Coordinator, husband, family, friends, and I had our fingers and toes crossed, hoping the blood test results would show that the drug did not trample my kidneys and liver while trying to clobber my cancerous tumor.

A comely female registered nurse, early 40’s, greeted me with a smile at the lab door. I raised my hand and said, “High Five!” She high-fived me and laughed as she said, “So, you’re the one.” Obviously Cleopatra had spread the word to the other bloodsuckers about the Celebratory One. The RN and I sat at our respective chairs in one of the curtained cubicles. She started moving around a circular rubber tubing with which she would strangle my arm above the elbow, a tray of color coded vials, brown elastic tapes, and other tools of the arm-draw option of bloodletting.

“So how many tubes are we going to fill up today?” I asked.

“Just four today,” she said knowing it would please the patient.

“Yes!” I stood up and pulled the air down with my fists, like athletes do when they score a point.

My jubilance got her attention. She asked her assistant across the hall to check on the Celebratory One’s treatment plan, just in case she missed something. Next thing I knew the assistant was in our cubicle handling the RN a plastic bag containing a plastic ziplok bag full of color coded tubes.

“So how many more?” I asked.

“Six, for a total of ten,” she said.

That taught me a lesson. Next time I’ll try to contain myself.

Every blood technician has a style but this RN’s method was the gentlest, so far, of the three that I had experienced in this lab. For the first time I even watched the blood being sucked out of my arm. Soon, she finished filling the ten containers and I went to the bathroom to get the urine sample. Then we said our joyous goodbyes.

I walked away from the lab buoyed by the knowledge that three tablespoons of my blood and a specimen cup of my urine will go far in advancing the development of a cure for cancer. The thought of my involvement in such a worthy humanitarian cause warmed my heart and moved me deeply. Am I a hero or what! I swear, if I start believing this, I’d soon be dusting my calligraphy pen sets and whipping up a Certificate of Eternal Gratitude to add to my impressive collection of self-awards. Hey, everybody’s entitled to a hangup!

My husband and I made a bee line to the hospital cafeteria to end my fast. I wolfed down a French dip sandwich in no time. After downing the last morsel of food, I sighed, Life is good!

Time came to see my Onc’s Onc. But first, the intake nurse had to do his thing: measure my weight and blood pressure. Blood pressure was high. I argued that my records show low blood pressure. He tried again. Still high.

At the examination room, another nurse took my blood pressure. Still high. I protested again. She totally ignored me.

My Onc’s Onc, stethoscope dangling from his neck, sashayed in and sat down in front of the examination table where I sat.

“What a beautiful wig!” He exclaimed. He said he had reviewed the blood test results and everything is normal. Then he asked, “Did you experience any side effects?”

“None at all,” I deadpanned, “except that I suffered a miscarriage.” The Trial Coordinator, my husband, doc, and I cracked up. The need to say something was overwhelming. Since I had nothing to say about the trial drug’s side effects, I talked about the effects of quitting Tarceva.

He noticed the high blood pressure readings. He stepped out and came back pulling a mobile blood pressure machine. First he checked his own blood pressure. It was very slightly high. “Shame on you,” I said. He took my blood pressure. Still high.

“This is unusual,” he said. “Hypertension is not a known side effect of CO-1686, but that does not mean you can’t be the first one.”

“That would be me,” I seconded, “always pioneering!”

He told us to meet him at the waiting room outside his office where he would give me a prescription for high blood pressure pills. As I walked closer to the waiting room, I saw a most incredible sight – my own Onc from Albuquerque! It was so strange to see him huddled with the masses waiting for his own Onc. Our eyes met and we did the hugs.

“Whoa!” said Dr C. “A reunion!”

For the first time I stood in the same room with my Onc and my Onc’s Onc. Dr C handed me the prescription. My Onc, my husband and I went to the cafeteria and exchanged stories for a little bit then disbanded.

My husband and I were pleased to know that the trial drug did not bother my kidneys and liver, but a little bit unsettled by the blood pressure issue. On our drive back home, we stopped at a CVS Pharmacy and Albertsons and took my blood pressure readings several times, desperately coaxing the machine to give a “below 95” diastolic reading. Never happened. At home we tried again. Still didn’t happen. That night, as instructed, I skipped a dose of the trial drug to see if the blood pressure would come down in the morning. Still didn’t happen.

“That’s it!” I was probably the only person in the world delighted to see a high blood pressure reading. “It’s not the CO-1686 causing the blood pressure to rise. I have simply come of age. Time for hypertension therapy!”

I had the blood pressure pill prescription filled, took the first one and resumed the six CO-1686 pills the following morning. Within the next hours, my blood pressure was back to normal. I doubled the warrior pose in my yoga routine that night to celebrate.