Status quo

About half-way through the second cycle of crizotinib. Pretty much just status quo. No new side effects. Nothing new to measure progress. A little more than a week until I get a CT and will have more definitive information regarding the progress of the test/study drug.

End of 1st cycle

Apparently, crizotinib is given in 21-day cycles and I have just finished the 1st cycle. So...I went in today for blood draw and an EKG first thing this morning. Then, saw Dr Einhorn. We discussed my status and side effects so far - basically, very minor stuff. Dr E signed off on the paperwork for me to start the 2nd cycle - which I started today. After that, I had lunch at the Bistro and had to wait 2 hours from the time I took the pills for another EKG and blood draw. At this time, everything looks good. Won't really know anything until 12/22 when I go back for the tests and get a CT.

It is different being in a study because I don't just keep taking the pills. I had to turn in the Rx bottles and remaining pills (along with my medication diary) and got new Rx bottles/pills for the next cycle. I guess they do that as a double-check to confirm the number of pills vs what I put on the diary. I did forget one evening dose so they would be able to see that when they count the remaining pills.

Thanksgiving

Turkey, dressing, ham, Jill's potatoes, green beans, sweet potato souffle, corn souffle, cranberry sauce, Connie's pumpkin pie - great meal. Follow that up with a little football and a nice nap.  Great Thanksgiving.

Crizotinib - day 12

So far I have not had any significant negative side effects from the Crizotinib - 12 days so far. I am still getting brief, minor trails in my vision - very insignificant. On the good side, my dry cough from the cancer has reduced quite a bit. The cough had become very frequent during the last few weeks before the new med. Now, it is mostly limited to right after I eat/drink and just a few other minor occasions. I will take that as a sign that the Crizotinib is doing something good. I see Debb (Research RN) in two days. I assume she will do blood work and other test. Not sure that she will be able to determine the impact of the Crizotinib yet.

Visual side effects

This morning I experienced a brief episode of visual side effects. When I woke up and sat up in bed, I experienced trails in my vision and ghosts in my peripheral vision. The trails are, basically, multiple repetitions.  The ghost was like if you filmed a flashlight in the dark with a camera using the bulb setting - meaning that you get this random etch-a-sketch in light. These are one type of side effect that is possible from the crizotinib. It was a very brief episode - gone in just a few seconds.

Crizotinib - start 11/11/10

Yesterday, I started the journey on crizotinib - the study drug that is very new. The routine is 250 mg in the AM and 250 mg in the PM.  This amounts to 2 large 100 mg pills and 1 50 mg pill twice each day.  The next time that I will really know about progress will be around 12/22 when I will have a CT.  I have a couple of appointments before then for labs, tests and to see Dr E.  But, the CT will be the real test of the benefit of the crizotinib.  Until then, my job is to take the drugs and watch for side effects.  I have anti-nausea meds in case I get nauseous.  Other than that, will have to deal with any other side effects as they come.  Dr E says that the typical side effects of crizotinib are normally less severe than I have dealt with from other chemos.  

protocol of one

So it appears that I will not be the patient 83 in the study protocol as originally planned. Rather, I will be on a new study protocol and that protocol will have one patient - me.  Apparently, there is more than one way to skin a cat; and, Dr E found a different way. They went to Pfizer, the FDA and the IU Internal Review Board with this new protocal with one patient.  And, it was approved.  This process is why the final approval took so long.  So, I have my first dose tomorrow.  I had to get blood tests and a CT today.  I will get an EKG before taking the dose. Then I will get another EKG two hours after the dose. Debb the RN will also give me a schedule of visits, tests, doses and apparently diary-like entries that I must do to follow the protocol. As long as I have instructions, I can follow those instructions. So...I will embark on this journey of testing a new cutting edge lung cancer drug. 

Great News!!

I was notified today that I have finally been approved to start the study/test drug for my lung cancer.  This was a great finish to about 3 weeks of frustration just waiting for final approval. 

Apparently, some of the tests done previously are now "out of the window" - meaning that I need to have the tests again.  So...tomorrow I go in for blood and other tests and a new chest CT.  Per Debb (RN), they are trying to get me going on the drug on Thursday.  We'll see...  I have waited so long that I won't be surprised if they can't get me going until Friday or even Monday.


Most importantly, I am pretty sure that they now have all the necessary approvals.  So...here we go...

still waiting

Getting final approval for the study is taking longer than I would like. Dr E referred to it as "bureaucracy". They have completed an Emergency Investigational New Drug application. Now waiting for review by the IRB - I assume that is an internal review board. Apparently, this IRB meets Nov 9.  So...it looks like we will have an answer then. The drug has been in the news and seems to now have a name - crizotinib.  I don't wait well.  But...that's my only option.

Waiting

Well...the lab came back with an ALK mutation negative - which would mean that I wouldn't qualify for the study.  However, we have previously had a test that showed positive.  So...DE is asking them to retest in light of the fact that we had a previous positive test.  All I can do now is wait.

Long day of tests

Today was a long day of tests to confirm qualification for the study of a new lung cancer drug being tested.  I have been previously approved by IU and the NIH.  However, now the drug maker, Pfizer, must agree.  I already had a chest CT last week (which indicated that my lung cancer is active again) and a brain MRI (which confirmed that I have no new brain lesions and no existing lesion growth).  Today, I had an abdomen/pelvis CT, a bone scan, an eye exam, blood tests, and an EKG.  I also met with the Research Nurse to discuss consent and process for the study.  If all tests are OK, I may be able to start taking the drug Thursday or Friday.  The ophthalmologist also determined that I have some type of irritation in my right eye that has caused a little edema (swelling) of the retina - which explains the red I have had in the right eye occasionally.  She will treat it with some prescription drops.

Life is odd

This week has been filled with fabulous Fall days.  Temps in the 60s and low 70s.  The leaves are turning beautiful colors - red, yellow, brown, a Fall rainbow of colors.  It has been an awesome drive to the office and the hospital.  And, there's the rub.  Lots of days at the hospital.  Days for Jill to go to her kidney transplant clinics.  (By the way, she is doing well.  She is planning to drive herself to her clinic tomorrow.)  Days for me to get a CT and and MRI.  One day, Tuesday, October 13, to learn that my lung cancer has once again become active.  Life can be such a contradiction.  Beautiful and harsh at the same time. 

Next week I go through a batch of tests to confirm that I qualify for this special no-name drug that will battle with my lung cancer.  Chest CT, Brain MRI, radioactive stuff injected to do a bone scan, CT on abdomen and hips, blood tests, EKG, eye exam and who knows what else. I will be glowing by Wednesday. But, hopefully, they will determine that I can start in the study of PF-02341066. 

I admit that I am a bit apprehensive.  I had hoped that this remission would continue for a few more months and would get us past the holidays.  That was not to be.  I am anxious to get going with this new drug.  I want to see if it lives up to its supposed success.  I'm the kind of person who likes to just jump into something, getting going, find out the side effects / deal with them.  I think that is the only way to really make the most of this kind of new drug.  So, PF-02341066 - let's get going.

10/13 - on to the next treatment

A CT scan this morning confirmed that my lung cancer has become active once again. So...I got 10 months from this last remission.  After discussing this with Dr E, I met with a Research Nurse to go over what needs to be done to start me on the new test chemo.  Apparently, the drug is made by Pfizer and they need to also confirm my qualification for the drug - PF-02341066.  I guess it doesn't even have a name yet.  They now have 83 patients in the study.  Next Tuesday, I will have a long day full of various tests and exams.  DE (the Research Nurse) will contact me with the schedule for the day.

I've been reading lots of paperwork about the study - various "informed consent" and disclaimer type stuff.  It also includes some details about things I will need to do - follow up tests, etc.

I am sure glad that Jill got through her kidney transplant and is well on her recovery.  It could have been pretty complicated otherwise.  We will still need to coordinate her follow ups with what I need to do. So...I guess we move on to the next adventure. 

hurray

Well...FB friends know that yesterday was my 36th Wedding Anniversary.  Jill and I have had a great life.  We knew each other in high school and went to the same college - where we became good friends.  It's a great thing to be married to your best friend.

She has had her own serious health issues.  We have been lucky that we have taken turns being in tough shape.  I was scheduled to see Dr E (my oncologist) today and she told me to tell him that it isn't "my turn" right now.  I did tell him that and he delivered great news.  I continue to be in remission!! 

He feels that I might expect to have a good run of time coming.  Whenever my current remission ends (hopefully, quite a while from now), I will go on the NIH test chemo which is a "specialty" chemo specifically targeted for a somewhat rare gene which I have.  He said that the NIH has had extremely good success with this drug; and, it apparently hasn't been causing side effects.  He thinks it is possible that I may have a couple years before it will be necessary to figure out a next treatment.

Nothing is ever guaranteed when it comes to cancer.  But, it sure is good to think that I may be feeling OK for a while.