Solo2 Clinical Trial

Princess Margaret Cancer Centre is a busy place.  I had to wait an hour to get my bloodwork done and then found out I was in the wrong place.  I have a port-a-cath and should have gone to Ambulatory Care for blood work.  Next time.

My appointment was for 10:30 but did not see doctor until 12:30 pm.  They are quite busy seeing the multitudes.  We left Princess Margaret at 2:30 pm.  We were there a full 5 and 1/2 hours.  I hope you never have to see an oncologist or the inside of a cancer centre.  Chances are you will because as people live longer their cells go haywire and cancer develops.

This was considered a first meeting and after discussing my medical situation the doctor seemed to think that I may be a suitable candidate for the Solo2 clinical trial.  This was not before he had to leave several times to confer with various researchers.  Seems most of my ducks are getting in order:  recurrent ovarian cancer, favourable response to a platinum drug (Cisplatin), BRCA2 carrier (they need to still see my genetic report from 2011), and CT Scans show some visible evidence of disease (they will have to verify this more).

They also decided I should finish up with my chemo treatments.  Usually a course of chemo is 6 infusions.  I have 2 more to go.  The study requires patients to begin the trial within 8 weeks of chemo ending.  Therefore, my last chemo should be the week of September 22nd and if accepted into trial I would begin no later than week of November 17th.  That is according to my calculations.

The drug they are testing is Olaparib.  As I stated in a previous post it is a drug that inhibits a cancer cell from repairing itself.  It is considered a maintenance drug which keeps the cancer from growing so that it lengthens the period of 'remission'.  That is what we are always trying to achieve although technically I have not been in remission since 2011.

Solo2 is a phase III trial and they are recruiting 264 people all over the world.  Because the researchers have not yet decided whether I qualify they wanted me to get registered in case the study closes between now and November.  If the study closes then I can still participate.  Of course they still have to definitively accept me into the study and I have to consent.  I was given a 23 page Study Information and Consent Form to read.  It is quite extensive in introducing the study, its purpose, a thorough explanation regarding its experimental status, charts explaining how often I need to visit hospital for tests and follow ups, all the potential side effects, my responsibilities as a participant, confidentiality, risks, etc.  I can drop out of study at any time.

On the one hand I hope to be accepted into this trial.  It is cutting edge science and could help me to attain some degree of remission.  Cost is picked up by drug company (AstraZeneca).  This study, if successful, could provide oncologists with another tool for maintenance treatment in future ovarian cancer cases.  On the other hand it is experimental.  Long term side effects are unknown.  Side effects while on drug could be unpleasant but maybe not.  At least with chemo my experience is a week of unpleasantness and a couple of weeks of normalcy of sorts.  And I could end up in the placebo group and get no benefit at all.  I still have several questions I want to ask of my assigned trial nurse and I have some time to fully consider this trial.

4th Treatment of Cisplatin

Yesterday I had the 4th and perhaps the last infusion of Cisplatin.  My oncologist received correspondence from Princess Margaret in reply to her inquiry regarding my good results from Cisplatin.  My CA 125 numbers have been steadily decreasing from a high of 597 in May to 60 on August 11th!  Very good response which means I am platinum sensitive!  Also, my CT Scan is showing shrinkage in my tumours which is also good.

Princess Margaret would like to speak to me regarding the Solo2 Clinical Trial.  This trial is for women with recurrent disease and with a BRCA1 or BRCA2 mutation.  Just waiting to hear for an appointment.  I am quite happy to hear about this but also full of questions.  It is a double blind study so I may end up in the group without actual medication just the placebo.

Next few days will be quiet while I relax with my side effects.  Right now I am still wired from the medications but I know I will be crashing later today and dealing with some nausea.  Good thing I have some great meds for that!

Update:  Appointment for Princess Margaret is August 25th.  That was quick!

3rd Treatment of Cisplatin

Just before my last treatment on July  22nd I met with the oncologist as we always do.  My CA 125 is now 150!  As you will recall this number was 597 back in May.  This is wonderful!  Cisplatin is doing the job of knocking down the cancer and we will go the full 6 rounds.  I should be finished up by end of September.

Treatment of Cisplatin is not easy as I have talked about in the the past.  I am admitted to hospital for a couple of days in order to get pre medications into me for 24 hours before we start chemo.  This is to prepare my body to accept (fool) the chemo otherwise I react severely and this is dangerous. I have been on this hyper sensitivity protocol for all 3 infusions.  I must comment that the medical personnel that take care of me while in hospital are fabulous.  They know me and know my situation.  I am under constant care and during my 6 hour infusion of chemo they are close by in case I react.  

It is now the 4th day after chemo with Cisplatin.  My constant headache has finally left me and I feel somewhat normal this morning.  The nausea has decreased considerably and I can manage to eat a regular meal.  Cisplatin has been the hardest chemo to deal with so far.  It may also be because of the pre meds as well.  I am very lucky to bounce back fairly quickly after my chemo treatments.  The tiredness and fatigue is very real but I am able to pace myself throughout the day with small rest periods so that I am not completely non functional.  Good nutrition and mild exercise is very helpful.

So Much to tell you.....

I know, I know, I have been really bad at keeping this blog up to date!  Well I have been living life and sometimes I just don't feel like writing!  :)

Since the last post I have had 2 chemo treatments and have been to Europe.  It has been a whirlwind of activity and now things are very quiet.

Just before leaving for France I was admitted to hospital on June 2nd for chemo.  I was given Cisplatin for at least 6 hours and prior to this I had 24 hours of pre treatment which consists of steroids, benedry, and cingulaire.  Because of my tendency of reacting to platinum drugs I need to be medicated to the hilt to receive chemo.  All went well and I had no reaction!  Thank goodness!  On June 4th I was released from hospital and went home to get ready for our June 6th flight to Paris!  Let me tell you my health was not the best.  After chemo I get some wicked headaches due to all the drugs and I generally feel poorly.

On June 6th we left for Paris and the flight was not comfortable at all for me.  After paracentesis the belly is tender and I still had some bloating which is uncomfortable.  My bowels are not at their best (to say the least) and I just was not feeling well.  However, we march on and try not to think about these things while on vacation!  We are in Paris! And what a great city it is!

The Iconic Eiffel Tower

From Arc de Triomphe

Arc de Triomphe

Notre Dame

Family members in Paris.  My Mom's Aunt and her family.

We met up with our friends, Jill and Michael.  We spent the rest of the week together in Paris and then moved on to Avignon in the south of France.

Don't Rain on my Parade.....

Things are happening again...........I was right as rain up until a couple of weeks ago.  It began with the bowels.  Why does it have to involve bowels?

So while attempting to inspire regularity I noticed my abdomen getting a bit bigger.  This was alarmingly noted when I tried on a straight skirt which I had made about a month ago.  I could barely get the zipper up.  Within days I had called the hospital and they arranged for an ultrasound.  They and I suspected that the dreaded ascites was back.  If you check out this link do not be alarmed by this picture.  I look nothing like that!  In any case can I tell you how bummed out this makes me feel?

Yes I stopped treatment in February because the chemo drug was not effective for me anymore.  But I had hopes that I could get through the summer without chemo.  To be able to enjoy a glass of wine with dinner would have been ultimate.  (little things make me happy.....)

Alas, I will be admitted into hospital on Monday for parensentesis and a chemo treatment.  The drug they are going to use is Cisplatin.  A platinum drug.  I believe Cisplatin was used in the days before Carboplatin and is still in wide use.  Because I react severely to Carboplatin I have to be admitted to hospital so personnel can monitor my potential reaction under a hyper-sensitivity protocol.  Best to be safe than sorry....

You may be wondering why on earth they would give me another platinum drug when I reacted to the other.  Platinum drugs are the best for ovarian cancer.  They seem to knock it down quite effectively but allergic reactions may occur like it does for me.  Also, the team at Princess Margaret suggested Cisplatin to my oncologist in order to determine whether I am 'platinum sensitive' or 'platinum resistant' after a series of infusions.  This was all explained in my post of April 17, 2014.  The ultimate goal is to get into a clinical trial with a parp inhibitor.  I have to qualify and this is the way.

My CA 125 is not good either.  My current reading is 597 and this is alarming.  I was at a low of 113 last December.  I knew it was rising but not this much.  I really need this chemo now.  The parensentesis and the chemo will take care of the ascites.

Oh and by the way ...... did I tell you we are leaving on a 3 week holiday in France and Spain?  In one week.  This was booked back in January after my Dad died and my Mom is coming with us.  At that time I was doing really well on Doxil and I had hoped I would be in good shape for June.  We are definitely going.  I just maybe not a bright as usual and I will have some good drugs to help me along!

Appointment at Princess Margaret

On Monday, April 14th I traveled to Toronto for an appointment at Princess Margaret Cancer Centre (PMCC).  I was to meet with Dr. Amit Oza to discuss clinical trials.  I actually met with Dr. Les Levin who is a member of the gynecological cancer team.  We had a great chat for about 1/2 hour.

He came to the meeting fully versed in my condition with the help of the summary provided by Grand River Cancer Centre.  He said it was a very good summary and the team had reviewed it.  I also brought with me the last 4 CT Scans and he had already reviewed those as well.

Basically, the end result of our discussion is that he and the team decided that it was unclear whether I am 'platinum sensitive' or 'platinum resistant'.  This is a very key criteria for the studies they conduct at PMCC.  I was unclear what these terms meant but he explained it very well.

Platinum sensitive:  When given a series of treatments of platinum based chemotherapy drug and a patient is disease free (not visible in a CT Scan)  for a period of 6 months or more months.  One drug of this type is Carboplatin.

Platinum resistant:  After being given a series of treatment of platinum based chemotherapy and patient shows growth of visible disease within 6 or less months.  The patient is said to be resistant to the treatment.

In my situation the team at PMCC doesn't know according to the information in my file.  My last treatment of Carboplatin in June 2013 resulted in a severe allergic reaction.  This was my second treatment in the series and my doctor and I decided we should stop treatment and take a break.  By September of 2013 my CA 125 was up 40 points to 386 and a CT Scan in October showed visible evidence of disease.  My doctor and I discussed using a different drug to avoid further allergic reactions and this is when I started the first of 5 treatments of Doxil.  When reviewing this information it is unclear whether I am 'platinum sensitive' because the number of treatments I had with Carboplatin were too few to determine what effect they had.  On the other had could I be 'platinum resistant' because I started treatment so soon after the last one but again it was only 2 treatments.  Perplexing as Dr. Levin expressed.....

Clinical trials are very regimented and almost of a military form.  The studies have to follow strict guidelines or else the researchers cannot draw meaningful conclusions which is what we want from clinical trials and the advancement of medicine.  So for this reason I currently do not qualify for any of their studies.  However, in his opinion, I currently do not show much disease growth in my CT Scans from January to March and thinks I should just take a break from treatment.  ( I am all for this.  My side effects are subsiding quite nicely.)

As a clinician he is suggesting my oncologist try another platinum based chemotherapy the next time (Cisplatin).  There is the risk of another allergic reaction but it would be administered while admitted to hospital.  This will help me in terms of disease management and to determine whether I am 'platinum sensitive'or 'platinum resistant'. In fact there are still many other drugs for the treatment of ovarian cancer that have not been used.  He mentioned gemcitabine, topotecan, etc.  I felt he listened to me and he answered all my questions.  I left there feeling quite optimistic and made my way in the rain to the nearest Winners store to shop before hopping the train back home.