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SORCE Sorafenib V's Placebo Trial

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

I have recently commenced the SORCE clinical trial to test Sorafenib V's placebo in non-met RCC patients to prevent recurrence.

Following radical nephrectomy I was categorised as high risk for recurrence and was offered placement in the 3 year SORCE clinical trial. I have read some interesting views on trial participation, with some people preferring to stay away from drugs unless they are 'absolutely necessary'. I am 32 and have a 13 year old daughter whom I am very close to. While I am not in a position where drug treatment may be said to be 'necessary' to preserve life - participation for me was a no brainer. The only available treatment for patients like me, that might help medical science and other patients, for free... yes please!

So here we are 5 weeks on... it has been a bumpy ride. Treatment was interrupted after just two weeks for grade 3 skin toxicity and high BP. Definitely on the active drug. Following one week off and another two weeks on, I am again experiencing some nasty skin complaints, nausea, fatigue, eyelashes are falling out, loss of appetite and general irritability. I am juggling treatment with parenting, work, uni and my only savior - exercise - has been reduced to a weekly yoga/barre class. I am feeling withdrawn and emotional - but I am persisting with treatment in the hope that my body will adjust if I can just stick with the program. I hope. I acknowledge the importance of quality of life - but I am so scared of not being around for my daughter that I will persevere. Also with the knowledge that there is no known treatment for high risk patients makes me desperately want to help in the quest of discovery.

If anyone is interested in the use Sorafenib/Nexavar, I will be happy to update as my journey unfolds.

angec's picture
angec
Posts: 614
Joined: Mar 2012

Hi Hanno, sorry to hear what you are going through. I know it has to be tough for you. I hope you have family close by or a good group of supporters to help you. There will be plenty here to cheer you on. You are doing fantastic and seem to be taking care of business quite well!

I don't know if you have posted your stats here such as tumor size, grade etc. It is brave of you to go on the drugs to help others. How do they measure results? I suspect you were NED. How long is the trial due to last? You do know that there are quite a few treatments out there now and several down the pipeline with less side affects. There will be plenty of options should you need them to keep you going.

Thank you for sharing and I wish you well. Enjoy those special moments with your daughter, they grow up so fast!

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

Thanks Angec!

What's NED? I think I posted stats here sometime when I first joined. Tumor was 9x8x6cm, extracapsular perinephric fat and micro vascular invasion. No mets or lymph node involvement. Stage 3, grade 2-3.

The trial is a double blind placebo controlled study. The three treatment groups are placebo for 3 years, sorafenib for 1 year then placebo for 2 years, and sorafenib for 3 years. Data is obtained throughout the study period with patients followed for I think 8 years total. Results will be measured through progression and disease free survival.

Please take note that I am no martyr - I am participating in this trial not only in an attempt to benefit others but also in the hope of preserving my own life :)

Thank you for your kind words x

angec's picture
angec
Posts: 614
Joined: Mar 2012

Hi there.. Yes I did some further reading and found your stats. Thank you for the information. I think just the fact that you even mentioned helping others, as well as benefitting yourself, is heroic! I am a caregiver for my mom and I am truly amazed at the power and strength being displayed by the patients, you included. I know that you are going to do well. And just the thought if there being lots of options just makes us all feel better.

NED is no evidence of disease. Sorry about that slip, I should have said it straight out.

So nice to meet you, looking forward to more of your posts. Take care and a big hug to you and your daughter!

Xxoo

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

No evidence of disease... thanks will remember that one now :)

Very nice to meet you also. I think we all draw inspiration from such different places. For me, a big chunk comes from people like you who are carers of patients. Another comes from teachers. I find that in kindness, there is amazing strength.

Warm regards to you and you and your mum. Chat again soon!

I am alive
Posts: 214
Joined: Jul 2012

Hanno,
You are so brave and smart for meeting this monster head on! I'm sorry the side effects are kicking in hard and early, but maybe your body will acclimate and they'll ease up. Anything can happen. I think it's fantastic that you and your daughter took an adventurous trip together, just the two of you, before you began your clinical trial. I want to do that with my girl soon. She was 12 when I was diagnosed, so I know how your heart breaks when you look into your daughter's face. My daughter's 20 now and I'm still here, so keep your chin up and your eyes on the prize. This is a wild ride we're all on. Ups and downs and sharp curves in the road, but the road goes on. Think of us as your traveling companions. Sending you love and good energy, and maybe a few roadmaps too!

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Hanno, we are VERY pro-clinical trials here. I would be dead by now if it weren't for my MDX-1106 trial. Instead, I am very well and will be around for a long time. What we have learned is that one needs to know what trials are available because the options vary greatly. Some facilities only offer some trials and not others. They will be therefore pushing their own trials. One may not be eligible for future trials based on participation in certain ones. Is that clear?I think I made it sound confusing.

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

Oh and Mr fox, your message was not confusing at all. I am very pleased you have found a drug that has worked for you. You've got the best attitude too :)

Before even being offered sorafenib I had done much research and found SORCE to be the only current trial for patients like me. I was, however, very surprised and fortunate to find it available where I live. I couldn't find any information to indicate that using Sorafenib now would exclude me from future trials OR make any of the known treatments less effective if I needed them later. My oncologist supported these views when I asked also. But I guess that's the catch - we just don't know what's around the corner in terms of trials and do we.

I don't take the shoulda view. Instead I just make the best decisions I can based on all I know now. The rest, well as they say, is history. Thanks Mr fox :)

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

Thank you. Traveling companions I can handle. You'd better send me a navigator along with those roadmaps though... I've got to be right up there for THE worst map reader award ever! :)

I expect to be around when my daughter is 20 too... but yes, sometimes I have to fight that overwhelming feeling when I look into those big eyes. You should book that trip.

x

fwhitex's picture
fwhitex
Posts: 5
Joined: Feb 2013

Hello Hanno

I have just come across your thread.

I to had non-met RCC. Diagnosed in December 2010. Radical nephrectomy Feb 4th 2011, I'm based in the UK, so the time scale to react is not so unusual.  Can't fault the NHS for the FREE service and health care I have received though.

Apparently tumour was PT2 Grade 4 (Surgeon said it weighed around 5lbs and about the size of a football, soccer ball for those in the US. Way too much info). By the way I was 46 when diagnosed. No family history, don't drink, don't smoke, overweight etc

I was offered the chance to join SORCE as well, a 'No brainer' as you say. Started in May 2011.

4 Tablets a day, two am- two pm. Loads of side effects but still worth it (Hair loss, upset stomach, sore scalp!, red face, skin problems - about 15 different side effects. Happy to say what they were if requested).

After about nine months I had a one week stop due to side effects. Then started on half dose = 2 tablets once a day. Side effects reduced but still have a few, which I'm happy to cope with, better than the alternative.

I assume you have the same follow up's in your country - 6 monthly CT scan - 6 Monthly Chest xray, 3 monthly blood test and discussion on how I'm doing.

Latest CT scan brought forward by two months due to a few issues with pain, discomfort etc. Hopefully body adjusting to operation two years ago. 

Very happy to compare notes or chat.

Also diagnosed as being diabetic in November last year (2012). Borderline type 2, so far diet controlled. Not good with only one kidney but life goes on and I'm fine with it.

 

Take care

todd121
Posts: 496
Joined: Dec 2012

Hi fwhitex. I was wondering if the diabetes was a side effect of the drug? I thought I'd heard some of these drugs can cause increases in blood sugar, but wasn't sure if this drug was one of those.

Wish you both well. Hope this works for you.

I just started the Everolimus trial. The trial you two are on has been closed to new participants. I'm anxious to hear some results from some of these trials.

Todd

fwhitex's picture
fwhitex
Posts: 5
Joined: Feb 2013

Hi Todd

Nobody seems to have linked the two.

I was a bit surprised as I have my blood checked every three months as part of the trials but I guesss they don't check for diabetes in these tests. I also did have a 'fasting' check four months before being told I am diabetic and this showed no signs of being diabetic ( I kepted getting sweats at all times of the day, which could have been a side effect or a sign of diabetes). Apparently I am 'just' on the level of being diabetic. Some have called this 'borderline' but my diabetic nurse is quite forthright saying 'you either are diabetic or your not diabetic, there is no such thing as borderline diabetic and you are diabetic'. As a say 'forthright'. 

I am quite a big chap and I do like my sweets, which I have greatly reduced, although not completely stopped (although I should - but you need a few treats in life).

 

Apparently I have 'sticky blood'. I was told this over ten years ago, nobody was concerned so neither was I. I beilive this is having a high red cell count, which thickens the blood somewhat.

I have become someone who notices every little twinge or creak and assume things aren't right. I'm sure I'm not the only one who does this.

 

I hope your trail goes well

 

Finlay

NanoSecond's picture
NanoSecond
Posts: 504
Joined: Oct 2012

Hi Findlay,

I hate to sound like your mother but several things concern me in your post.  You really need to consider getting that "borderline" diabetes under control ASAP.  Consider this:

http://jnci.oxfordjournals.org/content/92/3/192.full

http://www.sciencedaily.com/releases/2010/05/100521102629.htm

You certainly can control this by diet.  However, not by fudging on it.  Pun intended.

Also, have you discussed the possibility of taking the drug Metformin with your oncologist?  Here is an article that gives some background - there are many others:

http://cancerpreventionresearch.aacrjournals.org/content/3/11/1451.full

To add salt (or sugar) on a potential wound, you also need to pay close attention to why thick blood is another threat.  This one goes right to the heart of where (and why) new mets may appear.

Again this can easily be controlled by diet and certain supplements.

You might want to consider reading the book, "Life Over Cancer" by Dr. Keith I. Block to learn more about both of these threats - and several others you may not be paying attention to.

I have been "experimenting" with "proper" diet and certain "appropriate" supplements for some time now.  I take the maximum dosage of Sutent (50mg/day) and, so far, have had no significant side effects from it.  That too can be a benefit of proper diet.

Email me at: n.feldman@videopost.com if you would like a copy of my .pdf guide to what I am doing.  It is presently 45 page long.

-NanoSecond (Neil)

fwhitex's picture
fwhitex
Posts: 5
Joined: Feb 2013

Hi Neil

Thanks for your concern. I have radically altered my diet, lost weight, do more excercise. My levels are now in the norm, cholestral is down to normal. Blood pressure is in safe area (higher blood pressure is a side effect of the Sorce trial). An ongong lifestyle change that I don't take lightly.

I will have a read of the sources you quoted above.

 

Thanks again

Finlay

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Congratulations are definitely in order for taking the bull by the horns, Finlay.  It's always great to hear when someone takes control like that of their own health, which is just what Neil also did.

May I encourage you to dip into the material Neil has mentioned - it will help to consolidate your resolve and increase the excellent improvements you already made for yourself.

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

Hi fwhitex, it´s great to hear from another SORCE participant. You are the only other participant that I have found (or that found me..) who is still on the trial! Others that have contacted me either declined participation, or pulled out for various reasons. Sounds like you also have had a rough go with the Nexavar at times. I am guessing with the time frames you stated that you are on the 3 year treatment arm? I won't know until September this year if I'll receive treatment for 1 or 3 yrs... lately I've been secretly hoping it will only be 1 year... this stuff can be pretty nasty!

Wow your tumor was huge - such a sneaky disease to go undetected isn't it! I remember thinking how on earth could I not know that was in there?! I hope you have recovered well from surgery and that your up and coming scans go well - fingers crossed! Follow up protocol is the same as you - alternating CT/X-ray plus bloods every 3 months. I have my first CT coming up in a week or two. I'm definitely feeling a bit strange about it - anxiety and anticipation all at once I think. My scan will mark 9mths since diagnosis/surgery and 6 months on the trial. Who would have ever thought I'd be counting the months and weeks like I do hahaha. I think I also read that you have become someone who is sensitive to every ache and pain (at least I hope that was you?)... from all my communications across support groups I think this is normal. I think we all have good reasons to be fearful of recurrence or new growth - but it's about how much we let those thoughts bother us I guess. H
ope you are working through these emotions OK.

So, your side effects sound similar to mine - though I never made it to full dose. I've been on half dose since I started and have been pulled off I think 3 times now due to S/E. If I have to come off again for the same problems - I am started back at a quarter dose. I haven't found any research that supports half dose, let alone a quarter dose so I'm hoping that doesn't happen. I'd probably pull the pin. Hands and feet have been my biggest problem. And now half of my hair is gone. Showers are traumatic - just watching the hair wash away :( I'm hoping it will slow up soon though - my hair is getting pretty thin! Oh my goodness and the sore scalp you mention - so good to hear from someone who understands first hand (though I'm not happy you are going through this too) - my doctors said it was probably just the hand and foot syndrome affecting my scalp also. Just now starting out now on my morning coffee for the day - sitting on the deck overlooking the ocean. Life is good :) Might hold off on breakfast for another hour or so though - not sure if you are similar but once I eat my first meal for the day - the tummy battle begins hahaha.

All the best fwhitex, keep us posted on your progress!

 

fwhitex's picture
fwhitex
Posts: 5
Joined: Feb 2013

Hi Hanno

Sorry for slow response. I have been experiencing severe levels of pain and I now have intimate knowledge of every tile in my bathroom. My 6 monthly CT scan was brought forward, by two months, to give myself and my Doctor 'peace of mind'. After waiting 3  and a bit weeks for the results I'm delighted to say that I'm still cancer free, whoopy. They believe the pain, which is sometimes at similar levels as it was 3 weeks after my nephretomy, may be due to my body adjusting to bits missing inside me and the scar left after the operation. I used to get Doctors, nurses and medical students popping into the ward to have a look at my scar. It was somewhat disturbing/funny to hear them say 'wow, thats a big scar' and ' come and have a look at Mr white's scar'. 42cm (16.5 inches) in length, my 5 year old nephew insisted on measuring it (honestly). I guess my plan to be a swimwear model will have to be rethought.

With regard to the side effects - I have never considred leaving the trial. I was even disappointed when they reduced my dose from 4 tablets to 2 tablets a day, although the reduction in side effects was worth it.  On a day to day basis my side efects have reduced/gone and/or become part of my everyday life. I know that everyones reactions are different and it is very difficult comparing what you and I and others are experiencing. ie what I feel as pain with a level of 6, others may feel is level 3 and vis versa.

On a positive note, if I hadn't been on the trial I would still be waiting for a CT scan and would be imagining planning my funeral (pessimistic and over dramatic or what?). As a result of being on the trail it only took 4 weeks for my scan to take place, a major plus point of being on the trail. Also, looking on the bright side, I was already beginning to lose my hair, so now I can blame it all on the drugs - a great excuse.

No doubt you have already had a number of CT scans. I'm not worried in the least about the scan itself. It's all a bit 'James Bond', with the huge syringe type container with the contrast in within eyesight. I even quite like the taste of the drink you have to have over the hour preceeding the scan. The bit I don't look forward to is the needle for the contrast to be injected. Not that I'm scared of needles or the small amount of discomfort of the needle going in but I have terrible veins and it always takes a number of attempts to get the needle in the vein. The last scan was succesful on the third attempt, with 2 people trying at the same time. The worst was 8 attempts by 3 peope individually and then 3 at the same time - both arms, both hands, both wrists and both feet. I always mention that they will have fun/difficulty getting the needle into me. It is all a bit of a laugh (weird I know) and they see it as a challenge to get the needle into me in the least number of attempts. Getiing the needle into me usually adds 15 - 30 minutes to the overall time I am in the scan room. Its much the same getting blood samples as well.

I just realised that the above may make put you off your scan, sorry.
 

My Father had cancer (multiple myloma) at the same time I had mine; well sort of, he was diagnosed two years previously but we overlapped. I think there should be a rule stating that if a family is unfortunate enough to have one member with cancer, then no one else in that family is allowed to get cancer. I'm sorry to say that he passed away over 18 months ago.

My family have been brilliant and this has brought an already close family even closer together. Friends and colleagues have also been really supportive. I am willing (too willing?) to talk to any and all about things. My way of dealing, I guess. Make it all as everyday as possible and not lock it all away in some dark cupboard never to be talked about. I have always had a positive attitude (well most of the time) and this has certainly helped me to get on with things.

I hope your scan goes well and that your side effects and your discomfort levels decrease. Take care and I look forward to hearing good news.

 

Finlay (fwhitex)

 

todd121
Posts: 496
Joined: Dec 2012

After reading the two of you describe your side effects, I feel like I should be more grateful for my set. I've been on this drug for 3 weeks now. Monday night I had a case of severe naseau and dizziness, but I think I induced that with a beef stew dinner (I've been avoiding beef for weeks). Now I know to go easy on the beef. Mostly my side effects on Everolimus have been mild (if I'm even on the damn thing, could be placebo I suppose). I've been having nausea, fatigue, slight headaches, some insomnia, a sinusitis/rhinitis that has stuck around for 2 weeks (perhaps a sinus infection). I think I'm on the real drug. Monday night was bad enough that I got discouraged and considered stopping, but I stuck with it and today is better.

I need to remind myself that the point of adjuvant therapy is to kill the cells while there are few in numbers, and thus even fewer that might be resistant and hopefully the immune system will be able to overwhelm those last little bits. That encourages me.

I can't imagine taking the drug you two are taking for 3 years. I only have to stay on this for 1 year.

Similar to the two of you, I was stage 3a, grade 3.

Todd

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

My 9 month CT yesterday revealed no evidence of metastatic disease. Hoorah!! Whether or not the nexavar has played a part in this we'll probably never know. Either way I am very grateful for this result!

i hope that you are both doing ok and that Finlay, your pain has easing. This week I am feeling amazing... having yet another break due to side effects. It's funny how you don't realise how crap these drugs make you feel unit you're off them! Anyway, I see my oncologist tomorrow so we'll see where we go from here. 

Good luck guys,

Mel

foxhd's picture
foxhd
Posts: 1855
Joined: Oct 2011

Good job!!!!!!!!!!! Way to go! Now keep it up. Give us all more hope! Fox.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

Thrilled the latest reports are all positive! Way to hang in there.  

And so glad you're feeling wonderful. I'm a firm believer we have to feel rotten sometimes to appreciate feeling great. You've had your share of below par days; maybe this will be the start of a above par marathon! Enjoy!

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

Thanks Alice. I missed your post yesterday. You are spot on, boy do i appreciate feeling good! Even the little things... being able to go for a walk in the evening, not having bleeding gums when brushing my teeth, doing a normal poo! hahaha. And man are we stuffed when we lose our humor in those moments of vulnerability. Funny that you mention the word marathon... i was only a few days ago vowing to do a real marathon as soon as i am off tjis trial :) Take care Alice x

Alimac's picture
Alimac
Posts: 10
Joined: Dec 2013

Hi Finlay,

i hope you are still on this site and healthy? I am also in the uk and on the sorce trial at Addenbrookes in Cambridge. I was diagnosed with kidney cancer on 5/82012 as a 46 year old man and had the affected kidney removed approx 3 weeks later. It was checked and found to be stage 1 and grade 4. Due to the aggressive nature of it I was offered a place on the sorce trial, which I started on 5/11/2012. I am still on it and now on year  2 of 3. Loads of side effects and only a quarter dose as a result. Before I write any more it would be good to communicate with someone going through the same trial. I would be really pleased of you could respond? 

Regards

Ali

fwhitex's picture
fwhitex
Posts: 5
Joined: Feb 2013

Hello Ali

 

Sorry I didn't reply earlier. I havent been on the site for some time.

 

My three years trial is up on the 3rd of May 2014. Just been into hospital today for my 3 monthly blood letting and the results of my latest CT scan. All clear I'm pleased to say.

I wasnt sure what happens next but have been told I still go back every 3 monts for the next six months and then every six months (not sure how long for). Another CT scan in 6 months and then one a year for the next 5 years, which I am delighted about.

I have been on half dose for about 18 months and they certainly reduced the side effects to more livable levels. 

I will miss the tablets because it gave me comfort knowing that there was something that was helping to prevent any reoccurence.

Side effects, almost, blur into the background as they become so 'everyday'. Its only on extreme days or when they ask me at the consultation that I really aware of them (looking forward to not running to the loo and maybe some of my body hair will come back, not that thats a big loss).

I am still in loads of pain from the operations - medical advice is 'thats life' and 'take more pain killers. Long journeys are OK on the day but a complete nightmare for days after. Prescribed 8 Tramodol and 8 codine tablets a day. Not that I take them all the time - only when I need them. I believe your body builds up a tolerance to them and you would need to take them in larger and larger doses to get the same effect. Moan, moan, moan.

Not sure how we talk directly via this forum but if you want a chat I am more than happy to talk to you or anyone if it comes to that.

I was wondering do we get a big gold star or an award for staying on the trial?

 

Hopefully the results from the trial will help others.

 

Regards

Finlay

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

Docs confirmed today. Boy what a relief! I'm so gunning for everyone else here too :) 

Suekub's picture
Suekub
Posts: 112
Joined: Apr 2013

I have just joined this forum today. There does not appear to be anything here in Australia that offers similar experiences.

My story started in May 2011 when I had an ultrasound for occasional pain in my right side. This was immediately up with a CT scan which revealed a 20cm mass on my right kidney. Radical nephrectomy was done 4 weeks later. No mets which was fabulous and was offered a place on the SORCE trial. I believe I was on the drug for 12 months due to several side affects - hair loss, diarrhea, painful feet and fatigue. A few days after my 12 month on the drug I believe I was then taking placebo as I had immediate cessation of all symptoms. 18 month CT scan a couple of weeks ago has now revealed a lesion on my spine for which I commence radiotherapy this coming Thursday. I'm not sure of my treatment options after completion of radiation and will be discussing with my oncologist soon. Anybody have a similar experience?  

 

This cancer journey has been the most trying time and I try to stay positive for the sake of my teenage daughter who also lost her father (2 weeks before my diagnosis) as a result of metastatic melanoma. Life seems pretty unfair at the moment so would appreciate any positive stories.

 

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

I must apologise for not replying sooner. I am just now reading your message and wanted to ask how you are travellinG? I am so sorry to hear your family has experienloss such terrible loss in recent years.  I hope you are kicking the spinal lesion in the butt...

Suekub's picture
Suekub
Posts: 112
Joined: Apr 2013

I have recently done some posts which have updated my present situation. Regrettably I have been found to have mets to thyroid which necessitated thyroidectomy. Pathology was not what I wanted as there were positive margins. spinal lesion is pretty stable afteradiotherapy. Started Votrient about a month ago at 800mg but liver didn't like it so dose reduced by half and again liver enzymes went up. Now off it again and to be reviewed again next week.

hope you are doing well on the trial, didn't work for me but hopefully you will have better results.

Sue

 

 

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

My goodness Sue, you have been doing it rough haven't you. So disappointing that you went through a year of the nasty nexavar for no great benefit. I feel frustrated for you. I recently quit the trial. My quality of life became so dreadful on the drug that I forgot what it was like before it. I could barely walk. Constant diahorrea. My hair fell out. Fatigue. Depression. High bp. Then pnemonia. Enough was enough. Three months on I am not quite back to full capacity mentally or physically... but I am doing pretty good. i hope you have been getting some good advice from patrons on here, hopefully their wealth of experience will guide you. Sending a big hug your way Sue. And good luck with the review next week x

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