Cure Alveolar Soft Part Sarcoma International (iCureASPS)

Hi all my fellow asps warriors,
My name is Katrina, and this is my first post to let everybody know how my cediranib trial is going so far. Sooo.... Let me begin.
I began the cediranib trial in October, during those frequent hospital visits I met the trials clinical nurse who was taking on the study with my case- a Scottish man names Stephen, whom I can barely understand- lol! We work it out though! During these initial visits I had lots of bloods, weight checked, blood pressure, urine checks ect. I had to visit every two weeks to begin with.
Now... With the trial I am entered, it is a blind trial, so therefore I have a 1in3 chance of actually being on 'cediranib'. A very worrying prospect to deal with, when you know you really do not want to waste time with a placebo, but all in the name of research.

SIDE AFFECTS:
WEEK1:
During my first week of the trial I did suffer a couple bouts of dihorrea, but that was about it.

WEEK2:
I started to notice slight mouth sensitivity, the way your tongue feels after you burn it on a hot drink. I found it hard to use my usual toothpaste, so I switched to use my daughters Colgate toddler toothpaste, which is very mild, and a toddlers alcahol free mouth wash.
I also noticed again, very slight, hand and foot syndrome, my hands felt hot, and my feet began to peel. I also experienced some quick sharp pains in my chest, almost like I could feel exactly where my tumours were. I didn't experiance any dihorrea all week. Just a few stomach cramps.

WEEK3:
I have noticd that I have a loss of apetite, I get full quickly, and do not want any cooked foods, but would much rather snack on small bits throughout the day. I know that people have lost weight quite quickly on this trial,so I continue to force that little extra. I notice that my energy levels have changed, I am not so much physically drained, but moreso tired, sleepy tired, which is nice in some way. I felt quite nausous, moth sensitivity and hands remains very slightly sore. Unfortunately I suffered a severe onset of excruciating stomach pains, followed by sickness and vast amounts of dihorrea which continued for a few hours continuously, it resolved itself eventually. Although i must say the pain in my stomach was so sever that i was collapsed over my basin, unable to speak properly, and sweating with the pain. I will add that I have a very high pain thresh hold too.

WEEK4:
No changes really, feet had improved, hands and tongue remain unchanged. If anything starting to notice an improvement in my energy levels still, after recovering the exhaustion of last weeks onset.

Had my usual bloods, weight ect at the hospital this week, and it shows that my bloods are good, bp is good, and I lost 7lb. I was given more tablets to start second course-yes!

WEEK5:
Again no changes,no dohorrea. some bouts of stomach pain. found I am getting out of the house more now, and the stairs in my house are becoming easier to climb. I find that I have been doing a lot more chores in a day than I could manage before. Also.... It is easier to keep up with my extremely hyperactive four year old daughter.

WEEK6:
Unfortunately I suffered a severe onset of excruciating stomach pains, and an inability to pass any stool, it was the same pain and awful experience, as i endured during week three of the trial, only on a much higher scal in regard to severity in all aspects. I could not move any part of my body, sweating, and shivering, as i was so exhausted from the pain. Also joined by vomiting. I had the paramedics to my house and taken to hospital, where they found I infact had 'faecal impaction', I was treated with morphine for the pain, and an enema to correct the abdominal complications. I was allowed home that evening, even though extremely exhausted due to the pain I endured. I now continue to take laxido daily to help this issue.

WEEK7:
All week i felt very nauseated by the smell, look and thought of food. After my ordeaql last week,I was actually petrified to eat anyways. It all got me thinking, that if i hadnt forced myself to eat more than my body wanted, would have it prevented the onset?? Although I had experienced it before. We will see i suppose.

I had a visit to the hospital on the 15th december to have bloods, weight ect, I have lost a further 7lb. I also had my pelvis,abdo, and chest ct with contrast. As I have the scan in the same hospital as my usual visits, I thought they may have told me the results then...but no! I have to wait a whole month apparently, and they would tell me at my next visit. I actually refused to leave the hospital unless they told me something sooner, as in a month time, my scan results may not be true to that time. I left the hospital with a promise of results via phonecall in a weeks time.

I recieved my phonecall two days early, to tell me that I should go to the hospital in two days time, as my onc. Dr Dangoor wants to discuss my ct scan results with me. I asked if there was any knowledge as to why, and got no response. Sooooo, me being me, immediately demanded I get to speak with my onc, only for him to reveal that he tinks I actually have a couple of new tumours. The next two days were hurrendous for me, I was so scared that the trial wasnt working, and if i were taken off, I am told there is no more they can offer me in regards of treatments.

WEEK8:
Unfortunately yet again, I have suffered this sudden onset of stomach cramps and dihorrea, this time it lasted for around three hours, of which I could not even leave the bathroom, I had a couple bouts of vomiting alongside too. After i recovered from this, i felt absolutely fine again. altough a little tender for a day or two as before.
THE BIG DAY!!! TWO MONTH RESULTS!!
So arriving at the hospital incredibly nervous, my trials nurse tells me, 'I dont think the news is as bad as you may think'. So the results of my ct scan I can tell you from a very happy heart, showed NO NEW TUMOURS, some of my smaller nodules had grown very slightly, by a matter of mm's, and some of them had even reduced in size by a matter of mm's too. So overall statement from Dr.Dangoor three days before xmas was 'go and enjoy christmas, your disease is stable'.
The releif and sheer appreciation had me break down in tears, it would have been infact the first time i have EVER cried in the hospital. So i enjoyed christmas with a very happy heart, and a very overjoyed family, who now have restored hope. I just pray for continued success with this drug.

WEEK9;
Having been able to enjoy xmas with much happiness and hope, I am ever grateful. Although, I was not able to eat a great deal at dinner, my apetite seems to begetting smaller. I have found this week, having treated myself to a chocolate or two..... It made me feel quite nausious.
On the day after xmas day, my tongue sensitivity suddenly got worse, as did my hands and foot syndrome, all three felt like they were burning and my feet throbbing.
The following day it calmed down slightly, I dont know if I did anything to irritate it. I will keep an eye out for that though.

So guys, a very long update, but I want to include as much info as poss for use to everybody. I hope everybody is having a wonderful holiday season xxxx

Hi Katrina
I am glad you posted and so detailed! It will help others How are you an the lil one doing?

Hi Amanda,
me and Ella are great thankyou. We have had a lovely xmas. Xmas has knocked Ella from her routine, and as you already know I am a single parent, so this no routine lark, is proving very difficult- I am so so tired. The routine helps me too. I usually have Ella settled for 'quiet time' at 7pm, then we both go to bed together at 8.30pm, Ella does not sleep well at all, nor do I, so we both need a very long wind down before sleep time.
On the whole though, things are good. I dont see friends very often, so Ella is literally my everything, all day, everyday! lol! how are you doing?

Hi
I know the feeling of every thing being lined up and no rest when they are lil.. When things went off it was very hard to rest or get things done! I miss sleeping with Aidan he grew out od bear mode lol Xmas was wild and I *though I had a good time* am happy it is over with lol Are you going to come to the US any time ?

I would absolutely love love love to come over to the U.S, but my onc wont allow me to travel that distance on a plane because of cabin pressure. the past two times iv flown to spain (just 2 hours), I have had severe chest pain, not able to inhale or exhale fully, and a tumour bleed, and fluid. I have looked at cruises, but my goodness the health travel insurance will cost me more than the holiday itself-rediculous!

Katrina, you did a very good job and documenting it week by week - did you keep a diary?
This blind trial participation is very confusing, do you get the same (a drug or placebo) every week of the trial? I mean that if you started on a placebo - would you stay on it for all duration of the trial participation? Based on your side effects it looks like you are not getting a placebo but the real pill.

Hi Olga,
I was not instructed by mydoctors to keep a diary, which i feel should be done with all patients on a clinical trial, although I felt that if i keep my own diary, then this information can be of use to others at least.
I too was very confused by the 'blinded trial' aspect. The trial I've entered is actually a 'double blind trial', which is where neither the patient nor the doctors know whether you are on the placebo or cediranib. From looking at my CASPS patient trial information sheet, it says as follows:
RANDOMISE:- GROUP 1
(2 in 3 chance of being in this group- placed on cediranib for 24 weeks.

GROUP 2
(1 in 3 chance of being in this group- being placed on placebo for 24 weeks.

HOW WILL PATIENTS BE ALLOCATED TO THE TWO DIFFERENT TREATMENT GROUP?S:
To put it breifly, patients are picked at random via a computer programme to allocate which group they will be placed into.

WHY WILL SOME PATIENTS RECIEVE PLACEBO TREATMENT?:
The reason for using a placebo control is that the benefits from taking medication are not always due to the drug itself. These benefits are called the 'placebo affect'. A researcher must be able to separate placebo affects from the actual affects of the drug being studied. When a patient in a clinical study are randomly allocated, the researcher is better able to judge the actual affects of the drug being tested.

WHY IS IT NECISSARY FOR THE STUDY TO BE 'DOUBLE BLIND'?:
breaking it down- if the doctor has knowledge of whether the patiewnt is on placebo, or the drug being tested, it may influence how they judge the patients response to it.
If the patient knows which group they are placed in, then it may affect how they resond to it.

If within that 24 week period, the patient shows progression, the trial will be 'unblinded', if that reveals the patient was indeed placed on a placebo treatment, they will then be placed on the drug being tested,(in this case cediranib).
If the unblinding reveals the patient to have indeed been on the drug being tested (cediranib), then they will be removed from the trial, and other avenues will be looked into.

I hope this has made the 'blinded trial' confusion much clearer for anybody needing to understand more about it. dont hesistate to ask any questions

SIDE AFFECTS I FORGOT TO MENTION:

I forgot to mention a couple side affects I have noticed over these past weeks.
1. I have noticed on week three slight changed in my voice, I have lost control over most of my lower range, I soound somewhat of a teenage boy hitting puberty,lol. I tend to talk with a higher pitch to avoid these 'breaks and squeaks'.

2. In week 6 I had noticed that my skin was becoming increasingly lighter. Now... if anybody has been on sutent, you will know this is a common side affect of that particular drug, but as the weeks go on, I am definately losing pigment in my skin, although not my hair as I did on the sutent.

UPDATE- REMAINDEER OF WEEK 9:

So..... as I already have said in my previous update, xmas has been great, although I did struggle to eat a whole dinner. I can eat a slightly smaller portion of food than I give to my four year old daughter, and that will bloat me out. I find it easier to snack, so I went and bought some oat cereal bars, dried fruit and nuts, crackers, ect, just things that have carbs, so I can keep my energy up, but by only snacking. So this week I have found a couple more 'possible side affects':-

1. After eating apples, oranges, (acidic fruit), my stomach really burns, like it cant handle the acidity of the fruit. I know in the patient leaflet it states to stay away from grapefruit, which is very acidic, so i question whether this is linking up with my acidic fruit experinces.

2. I have furthermore noticed that my skin has lightened, I have had to buy a whole lot of new make up, as it has changed so much.

3. I weighed myself at home this week, as my appointments have changed at the hospital, so I was last weighed on 15.12.11, since then I have lost a further 5lb. With that there has been big efforts on my part to try and eat as much as i can. I actuallythink that there are some calculation errors on the first lot of weight loss, I will check those out properly, but I can say, on average it seems I am losing around 5lb every two weeks.

4. I am really struggling to sleep at the moment, I am literally up all night wide awake,as I write this it is 4.59am and I am still wide eyed and nowhere near sleeping. and having around two hours sleep a night. It could be due to the madness of xmas, or maybe connected, we will see, but I will be keeping tabs.

5. I have had some of those quick, sharp chest pains again, also a couple days where it feels like te centre of my chest is sore, I can mainly feel it when I inhale and exhale fully, been coughing alot this week too, but the temperature has been an average of around 4-5 degrees.

Thats all for this week guys.
HERES TO A SUCCESSFUL AND VERY HAPPY 2012 TO ALL MY ASPS WARRIORS!!!!!

Katrina
Posting as you do will help many in so many ways! It helps to see others have gone thru the samer things an what they did ... I dont think that the many that do not post understand that yet Ineaither case you are great and ty for all you are doing to help everyone <3

Happy an healthy new years to you two and to all our ASPS paitents and family <3

Dear Katrina,
Thank you for all of the invaluable shared very detailed and conscientiously documented information about your Cediranib Trial experience and results thus far. Shared anecdotal treatment information is truly one of our most powerful weapons in fighting this extremely rare and poorly understood disease, and everyone in the ASPS Community will be able to learn and benefit from the information which you have so generously shared. I only wish and Hope that more ASPS patients/family members who visit this site will also share their anecdotal information rather than just reading/taking the information that is so graciously given and offering nothing in return .
I am SO VERY happy about the encouraging results of your two month Trial status scans What a wonderful way to begin the New Year with good news and strengthened Hope in your dear heart! Based on your description of the side effects that you have experienced since starting the Cediranib, and my personal knowledge and observation of Cediranib side effects during the past almost 33 months of Brittany's Cediranib treatment, I think that you are definitely receiving the Cediranib instead of the placebo. All of the side effects which you have conscientiously described are ones which Brittany has also experienced. Some of the side effects have thankfully become less severe, but the chronic diarrhea, nausea, lack of appetite, and insomnia remain constant and very debilitating. If medical marijuana (which is legal in our state) is available to you in the UK, I would strongly recommend it as it is the only thing that helps reduce Brittany's nausea and makes it possible for her to eat and stabilize her weight loss. If medical marijuana is not available, then perhaps you could ask your doctor for a prescription for marinol which is unfortunately not as effective as regular medical marijuana, but it does help a little.
I will continue to closely follow your updates, and to hold very tight to Hope for a very successful response to the Cediranib and continued good news of stabilization of your disease and more tumor shrinkage/disappearance. Take care dear Katrina, give yourself and sweet little Ella special hugs from me, and keep in touch as you are able.
With special caring thoughts, Happy and Healthy New Years best wishes, and continued Hope,
Bonni

UPDATE:
WEEK 10:
So this week I have found my insomnia to have worsened. I am literally awake all night, and finally tired enough to sleep around 4am. It's insane!
I have also noticed that my gastric problems are worsening, the stamoach cramping are becoming more frequent, I have stomach spasms, griping pains, and some more frequent severe dihorrea alongside the cramping.
I have moreso lost my appetite, but I continue to push myself to eat. Although I had a very strong reaction to eating a slice of quiche. Shortly afterwards I felt extremely nausous, and vomited quite violently, the next morning I had severe stomach pain and dihorrea, I can only assume at this point that it was the quiche.
Very slight tongue sentitivity/hand and foot syndrome remain.

WEEK 11:
I have been feeling quite tired thus week, not fatigued but generally sleepy tired. Assuming its from the insomnia, which still remains. I had a couple of days this week where I had a severe onset of chronic stomach pain and dihorrea again. Noticing it was after eating a cheese sandwich, and a yoghurt drink the second time.
I have been busy this week decorating my house, as I thought I should make use if how I have extra energy since starting the trial. Although, asbo do not get hungry, it was very easy to forget to eat, so I now have set an alarm for every few hours, to remind me just to have a bit to eat, which helps.
Iv started to feel quite tender in my stomach this week, like its sore after I eat. I have had a couple episodes of vomiting after eating a meal, I really can only snack ido want to hold the food it seems.
Hands have been burning and tingling a little more than previous.

WEEK12:
AGAIN this week I have had a bout if severe stomach pain and dihorrea, which left me exhausted as usual from the pain. Still not sleeping, which I have come to the conclusion that it could simply be that I have more energy than I'm used to since starting this drug, which physically I cannot do much to release it.
This week my tongue sensitivity has increased that I am aware of it now, whereas before I only had to change my toothpaste. Now I cannot have ice cream, or a hot drink, or even.a mild coconut curry,lol. It feels like my tongue is on fire. I accidently had some pepper coated chicken, and after that one bite, it appears I had a blood blister on my tongue.
My hands have been burning and sire this week, I continue to moiturise each day, although it even hurts to open a bottle lid now.
I have taken record if my new stomach pains, and around 20mins after eating, my stomach feels as though its raw inside, and I can feel the food scraping its way through, very tender and sire. Followed by feeling very sick.
Also the groping pains I experience I have noticed are around 10 mins before excreting, which continues throughout and worsened until bowels are clear.

HOSPITAL CHECKS:
So I had a visit to the hospital for my weight, bloods, urine, and consult with the onc.
My urine showed high levels of protein, and my blood pressure was 133/94, on myast bp check it was at 97, so there were thought that I may be temoerarily taken off the trial until protein levels return to normal. Luckily after lab tests, urine and creanatine levels were fine the next day, and blood pressure which I didmyself today was 130/77. Bloods came back fine, so am able to continue the trial.

XRAY!
so I asked for my usual four weekly chest xray to be done whilst I was at the hospital, nothing to do with the trial. After looking at the xray with my onc, it shows continued stability of the disease, and possible slight shrinkage of the largest tumour next to my heart, and after measuring.one particular tumour, it showed a definate 1mm shrinkage. Some almost look as though they have disappeared, but I will await my ct scan next month as part if the protocol instructions, as we all know xray are not the clearest. So things are confirmed to be still stable at this point.
I'm due my ct scan the beginning of Feb, and my official trial update will be the 9th Feb, a day before my b.day.

Ok do another ling,detailed update, and as boring as it may be to read, I'm hoping by doing this it will help.
Take extra special care evrybody xxxx

Dear Katrina,
WOW! Waht an incredibly conscientiously written and detailed update on your Cediranib experience thus far! It is certainly not "boring to read" as all of the information which you have so graciously shared and so faithfully documented is invaluable to everyone who is following this drug. I am so grateful for your active participation on this site, and am very Hopeful that others will become more actively involved as contributors of shared anecdotal treatment information, rather than just as takers. We all need each other, and we need everyone's active participation and contributions to provide us with as much information as possible to help fight this insidious disease.
I am so sorry for all of your debilitating and painful side effects, but the good news is that based on those side effects, it certainly appears that you are definitely receiving the Cediranib rather than a placebo. The side effects which you descrie read like a duplicate copy of those which Brittany experiences. Brittany was so food sensitive that even catsup made her mouth burn, but thankfully that has moderated somewhat and she can actually now tolerate mild salsa . I Hope that your elevated blood pressure resolves and stabilizes as dangerously high blood pressure is a major concern and risk with Cediranib as you know. Thankfully, it has not been an issue for Brittany, although in the first few weeks of her Cediranib treatment she did experience a few blood pressure spikes. I am SO grateful and encouraged that your four week chest X-ray showed stable disease with no new tumors and some possible shrinkage and disappearance of some of your mets! I will be sending my very best wishes and most positive thoughts and energy your way for VERY good news on your four month Trial status scans on February 9th which I know would be the best birthday gift that you can receive In the meantime, please take good care of yourself dear Katrina, keep in touch as you are able, and know that you and your dear little daughter are held very close in my heart and my most caring thoughts.
With deepest gratitude for your gracious sharing, and with deepest caring, warm hugs, healing wishes, and continued Hope,
Bonni

Hi Katrina,

Thank you so much for your detailed postings!

Reading through your lines, I remembered the sleeping problems that Elisa had for a while (and still sometimes has). We suspect that it is linked to the fact that Cediranib de-balances a few things in the body, often also the thyroid function. Elisa's TSH (thyroid stimulating hormone) went up after having started Cediranib (already 21 months ago!), and since then she takes a very low dose of Synthroid. Once the TSH went back to close-to-normal, her sleeping problems became a lot less frequent. I don't think this was only a coincidence, so perhaps you might want to ask your oncologists about your TSH level.

With my best wishes,

Johannes

Dear Katrina,
Are you on a 30 mg. daily dosage of Cediranib? This seems to be the standard dosage now given in the Cediranib Clinical Trials since it was determined that the initial Cediranib Clinical Trials dosage of 45 mg. per day was too toxic and not well tolerated, as we experienced in Brittany's case and also as was the case with Paul Mavers who was one of the first ASPS patients who received Cediranib and had a successful response to it. Brittany's excellent Clinical Trial oncologist, Dr. Michael Sawyer, has discussed the possibility of reducing Brittany's 30 mg. dosage further to try to alleviate some of her harsh vomiting side effects, but Brittany and we have been unwilling to do so thus far fearing that a lower dosage might not be as effective and would possibly result in disease progression.
Thank you Johannes for your valued sharing and input regarding Elisa's Cediranib caused insomnia, and CONGRATULATIONS!! to Elisa on her now 21 months of disease stability since beginning her NIH Cediranib Clinical Trial. It would be deeply appreciated if you could also post a brief update on this Cediranib thread regarding Elisa's Cediranib treatment experience and results thus far and her current status relative to tumor shrinkage/disappearance.
Also, have either you Katrina and/or Elisa and you Johannes been notified in writing or verbally by the Clinical Trial oncologists/staff about AstraZeneca's planned discontinuation of the development of Cediranib and ultimate closing of all Cediranib Trials by the end of 2012? This decision is certainly of immense concern to all of us in the ASPS Community and something which needs to be addressed and appealed.
With special caring thoughts and continued Hope,
Bonni