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.

Visit with doctor at London Regional Cancer Centre

Earlier this week on March 4th I met with Dr. Welch out of LRCC to discuss clinical trials.   

We discussed my medical journey thus far and some of the work he is involved with.  Unfortunately, one of the trials he is managing was unsuitable for me because I went from a platinum based treatment to Doxil last year.  His trial wants candidates straight from platinum based treatments.  As you may recall I have a sensitivity to Carboplatin (platinum based) and went to Doxil treatment last September.  

One of the things I wanted to talk about was the timing of entering clinical trials.  It is confusing to me.  Do I continue on a treatment as long as it is working and miss out on a clinical trial using an experimental drug that might do me good or jump into a trial as soon as possible?  Naturally there is no hard and fast rule about this and he confirmed this.  He did talk about a trial starting in several months that I may qualify for and he will keep tabs on me for this.   We also talked about Princess Margaret Cancer Centre in Toronto and how this might also be an option for me.  That facility does attract more research dollars and cutting edge trials which I am interested in.

I should probably talk a little about clinical trials.  By the time a treatment needs to be tested it has been studied extensively in research labs and probably tested on animals.  My understanding is that there are 4 phases and the process generally takes many years:

Phase I:  Answers the question 'Is this drug safe.'  Drug is tested for first time on humans and on a small group (15-40).  Generally the people in this trial have no further treatment options.  Usually conducted in major teaching hospitals.

Phase II:  Answers the question 'Does the treatment work?'  The people in this phase (25 - 100) usually have the same type of disease and they all receive the same dose of the drug.  These people have not responded to standard treatment or are more likely to benefit more from experimental treatment.  These trials are usually conducted at major teaching hospitals or smaller community hospitals.

Phase III:  Answers the question 'Is this treatment better than existing treatments?'  When enough people respond favourably to the treatment in phase II then it enters phase III trials.  Several hundred people are usually involved and conducted across Canada and North America at the same time.  Trials are usually randomized in that the participants are chosen at random to receive either the new treatment or standard treatment.  The trials may also be blinded in that the participants and / or the researchers don't know which treatment the participants are getting.  This is all to support scientific study objectivity and reduce human bias. If phase III is safe and effective then drug manufacturer can apply to Health Canada for approval to sell the drug by prescription in Canada.

Phase IV:  Answers the question 'Is there a better way to use this treatment?' These trials study drugs that are already approved by Health Canada and  are being used for standard treatments.  Researchers may use these drugs to better understand treatments that have already been proven to work.  A trial may show that a drug is more effective if it is given for a longer period or that a lower dose works as well with few side effects.  

Dr. Welch was gracious and empathetic to my situation.  If I do go to London to participate in a clinical trial I know I will be in good hands.