Brittany on Cediranib trial Phase 1 in Edmonton

[Olga]

I've opened this thread for Bonni/Brittany to post their experience on a cediranib trial that Brittany started in Edmonton/Canada. It is one of a very few locations that are still open worldwide. As per our oncologist, this trial in Vancouver is closed for enrollment and despite that it is listed as open at the clinicaltrials.gov the company ignores all their attempts to enroll a few additional ASPS patients and does not even answers their requests. Ivan was pre-screened for this trial in December but they did not get a single space on a trial since then.

[Brittany Hess]

Hey all, Brittany here! Thanks for opening this thread for me Olga We are in Jasper National Park right now, trying to kill some time until I start taking the medication. I start taking the Cediranib on Tuesday. I have spent the past week doing many different tests, i.e. various blood work, ECG's, and chest/abdominal/pelvic CT...new patient orientation (which I felt like I could teach the course, actually!). I met my doctor (Dr. Sawyer) and the 2 nurses that I am going to be seeing a lot of in the coming weeks. I must say, everyone has been so incredibly nice and with really good senses of humor (which I have felt on my 8 year journey is a huge part of healing and being able to retain a positive attitude). It sounds like I am going to be kept fairly busy! Somedays I will be spending 8 hours or so at the hospital having multiple ECG's (I think somewhere around 8-10) and a lot of blood draws (about 10 as well...they will just keep the IV in my arm so I don't have to be poked a lot!). Side effects are obviously a little different for everyone. Mos peoples blood pressure has sky-rocketed, which is why they are keeping such a close on that (I will be taking my own BP several times a day even when I'm not in the hospital...I'm a CNA, so that comes natural to me I know that extreme tiredness seems to be the biggest side effect as well...I'm going to try to keep myself busy so hopefully I won't feel like sleeping even more. Ever since my second cervical spine surgery I have had soooo much pain, I'm in agony at all times...this keeps me from being my normal self (traveling the world, riding my motorcycle, etc)...so I just hope that this chemo doesn't bring me down even more. I really look to Paul as my inspiration here. I keep telling myself that I will be able to handle the 45mg just like him, and I will be able to keep living my life to the fullest just like him! Everything I've ever put my mind to, I've been able to accomplish, so I just know that this is going to be the same way! I thank you all for your continued support and love for me...I tell you all the time...that's what keeps me going! I will give you an update as soon as I start the trial and let you know what I'm feeling and how it's affecting me (if I don't feel up to it...I know my mom will, that we can always count on!) I love you all! Wish me luck!!!

[jcs2007]

britanny,
Thanks for you update. Yes, the trials do require one to do many tests and long days at
the hospital. We have found a sense of humor and a lot of reading material
does make the time go by faster. Just wishing much Luck and Blessings on this next
journey. Stay strong and keep us posted as you can.
Cindy

[Brittany Hess]

Ok, so this is going to be round 2 to writing this update and it’s not going to be nearly as long or detailed, because it’s 2am and I’m tired and frustrated that it was all erased previously.

So, first off, I just wanted to agree with Ivan and the whole thing about Edmonton being as exciting as living on Mars…that is definitely not in a good way! Once you’ve been to the “biggest mall in the world” once…you kinda don’t ever need to be back again. We went to Jasper National Park for a few days the first weekend, Calgary and Banff the next, and a ridiculously stupid place called Elk Island the next (for Mother’s Day) in which we saw 2 buffalo and 1 duck! To explain the boredom in our family: sitting in the hotel room, my mom will be watching news, while my dad and I instant message back and forth on Face Book 5 feet away from each other! Lol! It’s quite sad! Luckily, I had a 6 day break, in which case we drove 9 hours to our second home in Montana where we got to see 3 aunts, 2 uncles, and a cousin…and of course my brother Tate buried there as well. We had nice sunny weather unlike the snow in Edmonton. My Aunt Linda (my inspiration in life, a 20 year Multiple Myeloma cancer survivor) has joined us on our trip back to Edmonton. We head out of here again tomorrow and back to Montana again for a few days (including an appointment with a pain doc that’s going to give me a botox injection that will hopefully get rid of my constant agonizing back pain). We return to Edmonton on the 24th for a short 4 hour appointment on the 25th…and then I get to head back to Seattle! Yay! I will come back to Edmonton again on June 19th for a chest/abd/pelvic CT with results on the 22nd. I will update when I know anything. 

Ok, so let me go over the past few weeks. The very first week is when I had all the screening and stuff that got me into the trial. The first week of the actual chemo goes as follows: Lots of blood draws, ECG’s, vital signs, urine samples, and questions! My side effects not being so bad at this point. I was having some dry skin patches on my arms, really dry throat and mouth/tongue, trouble swallowing, heartburn/acid reflux, slight headaches and nausea and that seemed to be it.

The second week, the Rifampacin was added. It seems to have more side effects than the Cediranib…which really is a good thing, since the whole reason I’m on this trial is to get the Cediranib, not the Rifampacin! The main side effect and most common of the Rifampacin is that your urine turns orange. Any of you women out there whom have had UTI’s, probably have dealt with the orange pee thing when dealing with the anti-spasm med that comes with having UTI’s! Also, my number 2 turned a little orange as well, as weird as that seems! Another one of the main things that they have you keep an extra close eye on, is the high blood pressure. It especially happens with the combo of the 2 meds. I’m supposed to call the triage nurse if it hits 140/90 and stop the med if it reaches 150/100. Luckily my blood pressure has always been at an average of 98/60 so I have quite a big buffer before I have to start getting too concerned. Well, the most mine hit on the combo of meds, was 130/87…came close with the diastolic, but never quite made it to anything to be concerned about. I’m very thankful, because I really didn’t want to go on any blood pressure medication. Oh yeah, another side affect that really popped up in the second week, was the mouth/tongue sensitivity. I’m somebody who puts hot sauce on just about everything…but no longer! Hot sauce just about had me blow a gasket! Even some cheese/broccoli soup I had (as bland as that sounds) had my mouth on fire for hours, no matter how much water I swished in my mouth. Get this, even cold water started feeling like it was burning me! The nurses suggested that I swish my mouth around with club soda several times a day, and it seems to have helped quite a bit. I started having quite a lot of diarrhea as well. Oh, and my muscles, joints, bones started aching quite a bit too. Kinda reminds me of when I was on steroids (Decadron for 9months).

In my third week, I was taken off the Rifampacin. My urine went back to normal, my mouth sensitivity is still there but not nearly as extreme. The latest thing going on with me is this nail bed sensitivity situation, and these strange reddish/brown striations on the tips of my nails. Of course when I did research on it, the first thing that popped up talked about Melanoma. Which was a big red flag for me. Since there seems to be such a close genetic resemblance between ASPS and Melanoma…it really made me think. Maybe my nails were this way because the cancer is getting irritated in there by the chemo so it has things enflamed a bit. I showed Dr. Sawyer (the lead Doc on this particular trial) and he wasn’t too concerned. In fact, he thought that they very much resembled something called Splinter Hemorrhages. Which really starts to make tons of sense when this chemo cuts off blood supplies. Anyway, I first noticed these weird markings when my nails felt really tender. It started at first when I opened a pop can and then I even felt it as I was typing. When I told the nurses and they wrote it in my chart, I started studying the actual nails and saw this and then researched it. So, that is the latest side effect. I continue to have really sore knees and shins. My energy still seems very good as well. In fact, my mom keeps accusing me of slipping her and my dad the chemo, since they seem to be resting a lot more than me! My back and neck have been in severe pain. I think that this is because for all I know I have some residual tumor in my back that has swelled up a bit. You know how things tend to swell up before they die. It’s just a thought. Also, I have these tumors in my “guts” as you all know. The pancreatic one being the one that scares me the most, but it’s the one in the small bowel (inter…) that worries the docs most. If it gets too much bigger, it will cause a small bowel obstruction and require surgery. But, if I have surgery for anything related to this cancer, I get kicked off the trial. So, the hopes are that this chemo will shrink that tumor. But, along with the theory that things swell before dying…this could cause a problem for me. Anyway, the other day we went back to the mall. Last time we went, I required a wheelchair because my back was hurting so bad. This time, I was able to walk around for 4 hours without my back causing me entirely too much pain…maybe the cediranib is helping now, I don’t know. But, by the end of that mall trip, I was doubled over in pain, walking around bent over as I b-lined it for the car to go lay down. My lower abdomen was in so much pain I couldn’t hold in the tears. I’m afraid that maybe I’m starting to have the obstruction they were concerned about. Earlier that day, I had had my normal 7AM appointment with the normal vital signs, blood work, Urine samples…this time for once there was no ECG, but we did meet with the doctor. He did a quick physical on me and said that everything is looking fine, my lymph nodes and everything felt just fine. He felt my abdominal tumor (the one that is very apparent, even to the naked eye. About a year ago I could only feel it and not see it. At that point it felt the size of a pea, since then it has grown to the size of a marble) and asked me if I thought it had shrunk at all, I had said “no, I feel it several times a day and it feels about the same”. He said that maybe since I feel it everyday, I wouldn’t notice it shrinking, but since he hadn’t felt it in 2 weeks, he could tell better than me. Bottom line, without measuring or scans or anything, just to his touch he thought it felt smaller, so that was good news for sure  He gave me the OK to get out of there and head back to Montana.

Another long drive to our second home….so good to be back again! I had an 8AM appointment with my pain doc in Kalispell to get some Botox injections. He gave me about 8 shots, the size of the needle horrifying my parents, but they said that I didn’t even flinch the slightest bit. I’m so used to so much pain, it hurt quite a bit, but, whatever…just a few shots. The doc said it could take about 3-4 days for me to notice anything. When I had the trigger point injections, it was like a miracle…I had the first relief that I could feel in a year!...those only lasted 4 days, but it was the best 4 days of my life…I’m so hopeful that this botox will kick in and have the same effects on me. Not yet, but I’m still holding out hope! Anyway, yesterday would’ve been my brother’s 34th birthday, so I sat out at his grave for about an hour and a half (from 10:15 am to 11:45)…apparently this chemo must have some sort of extreme sun sensitivity, because even though it was such a short time and in the morning- I am burnt to a crisp! Nobody else in my family got an ounce of color, just me! Also, I had a few shots of Jack last night (in memory of my brother-his favorite drink)…it made my blood pressure skyrocket. So, I think that drinking and this chemo don’t go together very well either. I know that I’m weird and usually the opposite things happen to me than to most people, but I hope that that doesn’t happen with the Cediranib…I want it to work! I still don’t have the extreme exhaustion, in fact, I feel like I have a little more energy now. Also, even with the amount of nonstop talking I do (trust me, I’m kinda obnoxious) I still have not lost my voice or gotten the hoarseness that they talk about. We shall see. We will drive back to Edmonton again tomorrow for my Monday appointment and then home sweet home for me! I will let you all know if anything changes for me, physically, mentally or whatever. Thank you all for the continued love and support. Talk to you soon!

Love,
Brittany

[Bonni Hess]

Dear ASPS Community Friends,
Last Friday, June 19th, Brittany had her two month chest/abdominal/pelvic CT scans in Edmonton to try to determine the effectiveness of the Cediranib treatment thus far. On Monday, June 22nd we received very good and encouraging news from the scan results which thankfully showed no new tumors, shrinkage of some tumors, very minimal growth (one to two millimeters) in a couple of tumors, and most encouraging of all, the very concerning small bowel intussuseption tumor appears to have completely resolved and disappeared! Brittany's excellent Clinical Trial oncologist, Dr. Sawyer, is very encouraged by the results, and said that his close examination of the scans shows that the make-up of the tumors appears to be changing indicating that the tumors may be developing holes caused by the medication cutting off the blood supply to the tumor. We had additional good news two weeks previous to last Friday's scans when Brittany's nearly four month post-Gamma Knife brain MRI which was done in Seattle showed no new tumors and apparent shrinkage and necrosis of the Gamma Knife treated brain mets, with two of them no longer even visible on the MRI! Brittany has been tolerating the 45 mg. dosage Cediranib well with only minimal side effects, but concerningly she experienced a sudden onset of severe nausea, vomiting, and diahrrea on Sunday when we were in Edmonton which required emergency room care and hospitalization for three days. It has still not been determined if the vomiting and other symptoms were caused by the flu, or if it is related to the Cediranib, but Dr. Sawyer had Brittany temporarily discontinue the medication for two days. Thankfully, the symptoms have now resolved, Brittany was discharged from the hospital yesterday, and was able to fly Home to Seattle. She resumed taking the Cediranib medication today, and we are Hoping that the vomiting and diahrrea will not return. Also, Brittany's blood tests showed that her thyroid levels are starting to decrease, which is a common and expected side effect of tyrosine kinase inhibitors like Cediranib, so Brittany will begin taking Eltroxin 0.1 mg (100 micrograms) once daily to try to increase the thyroid levels to normal.
Brittany will continue to take the 45 mg. Cediranib as long as she is tolerating the medication with no severe side effects. She is scheduled to return to Edmonton in a month for blood work, and blood pressure and EKG monitoring, and then she will return again the following month for her four month Clinical Trial scans. We are holding VERY tight to Hope that the Cediranib will provide continued disease stabilization and tumor shrinkage. I will keep this Forum updated, Hopefully with continued good news. In the meantime, please take care everyone, have a beautiful summer blessed with the miracle of healing, and keep in touch with the Web site as you are able.
With special caring thoughts and strengthened Hope,
Bonni

[Olga]

Bonni,
I am thrilled to hear this news, this drug is a very promising candidate for ASPS treatment and I am so hopeful that Astra Zeneca will see their advantage of having the ASPS specific multi-center based Phase 2 clinical trial ether as a single agent or in a combination with something.
I am sorry to hear about the side effects emerging on this pretty high dose 45 mg, would be Brittany able to lower her dose if the toxicity will increase again (after the consult. with a doctor) or she will have to travel to Edmonton to do that, is it a single pill or it can be divided somehow to lower the dose?

[Bonni Hess]

Dear Olga,
Thank you for sharing our good news with so much joy and special caring, and with your kind words of support and encouragement. Regarding your questions about the possibility of reducing the Cediranib dosage if the severe gastrointestinal symptoms and side effects resume, yes Brittany would be able to reduce the dosage within the Clinical Trial protocol a maximum of two times to a minimum dosage of 30 mg. without having to return to Edmonton for the reduced dosage. She is currently taking two pills daily, one which is 30 mg. and one which is 15 mg. so she would just need to discontinue taking the 15 mg. pill, but we are Hoping that she will not suffer any further severe side effects which would necessitate a reduction in the dosage. I will keep this Forum updated. Take care.
With deepest gratitude for your special caring, faithful friendship, and strengthening support, and with continued Hope,
Bonni

[Olga]

Bonni - another question if I may - about the responsive metastatic sites, you said that some of the mets have shown a very slight increase (and you know that in some cases necrosis associated inflammation can look like a very small increase) but some other mets have shown some shrinkage, can you comment on what metastatic sites have shown what.

[Arch]

Bonni, Thanks for sharing this excellent news. Convey our best wishes to Brittany and all of you take care.

[Bonni Hess]

Thank you for your kind words and good wishes Arch. Regarding your question Olga about the location of the metastatic sites which showed some shrinkage and some increase, the majority of the innumerable pulmonary nodules throughout all five lobes of both lungs have remained stable. The three target lesions (those which are being followed and measured for the Clinical Trial) in the right lung have all decreased in size one to two mm. Within the left lung, a crescentic shaped to cavitated mass has decreased in size from
5.0 cm x 3.1 cm to 4.2 cm x 2.2 cm, and the left upper lobe nodule has decreased from 1.9 cm x 1.6 cm to 1.6 cm x 1.4 cm. The subcutaneous nodule within the left upper anterior abdominal wall has mildly increased from 1.5 cm x 0.8 cm to 1.6 cm x 1.0 cm.
A very large partly necrotic portacaval space lymph node (which we think is the previously identified pancreatic head met, but we still have to clarify this with Dr. Sawyer), has slightly increased from 3.5 cm x 3.4 cm to 3.9 cm x 3.3 cm, and a lesion located along the left lateroconal fascia, just inferior to the spleen, has slightly increased from 1.4 cm x 1.2 cm to 1.5 cm x 1.4 cm. We were of course Hoping that all of the mets would show shrinkage, but we are holding very tight to Hope that the slight increase in some of the mets is due to the necrosis associated inflammation which you referred to. Because there are no new tumors and there is stability or shrinkage in most of the tumors, and based on Dr. Sawyer's highly respected opinion that the makeup of the tumors appears to be changing, we are cautiously optimistic that the Cediranib is working. Hopefully the four month Clinical Trial results scans in August will confirm this and will provide strengthened Hope.
With special caring thoughts and continued Hope,
Bonni

[Amanda]

Brittany and Bonnie! :::Does a lil snoopy dance::: YAY!
This is wonderful news indeed!
I just posted to you in updates and will now try and pull my post because of the posts i have read here.
I cant tell you how happy i am!
Every night are prayers are with you both and they will continue!

In happy tears and huge hugs!

AmandaR

[Fictional]

This is wonderful news, Bonni and Brittany. Hooray! Will pray for continued work attacking the tumors - excellent too if the tumor is in a lymph node rather than the pancreas.

[Bonni Hess]

Dear ASPS Community Friends,
I'm sorry to have been out of touch with the Web site, but Jim and I have been in Montana, and traveling and camping there for the past several weeks. Heartbreakingly, Brittany was rushed to the emergency room on Monday night with a sudden onset of severe, repeated, and uncontrolled vomiting, and was then hospitalized in Seattle. I flew from Montana to be with her on Tuesday, and after three difficult days of trying to stabilize her vomiting, nausea, and diahrrea with several anti-nausea IV medications including Zofran, Compazine, Raglan, and Ativan, her symptoms were finally resolved and she was discharged from the hospital this afternoon. Brittany discontinued taking the 45 mg. daily dose of Cediranib on Tuesday through today at the recommendation of the Seattle doctors treating her at the hospital, and with Dr. Sawyer's approval. Abdominal X-rays and an abdominal CT with contrast thankfully showed no blockage or tumor which might be causing the severe gastrointestinal problems, so the doctors feel that they are most likely a direct result of the Cediranib which is probably causing inflammation of the bowel. Because of the severity of Brittany's gastrointestinal side effects and the fact that this is her second severe gastrointestinal incident in the past five weeks, Dr. Sawyer has now recommended that she decrease her Cediranib dose to 30 mg. per day. He wrote to say that "the early studies with AZD2171 in phase I showed that 45 was tolerable and the recommended dose; later studies and investigators suggested that although 45 was tolerable 30 was more tolerable in patients who were on it for a long time. I favor going to 30 as this is the second episode of nausea and vomiting, we had another patient with colon cancer who ran it a similar thing after your experience and we reduced her to 30 with resolution of her symptoms and continued stability of her disease." Brittany will begin taking the reduced 30 mg. dose of Cediranib tomorrow morning, and will Hopefully be able to tolerate it well with no re-occurrence of the vomiting, nausea, and diahrrea. Her four month Clinical Trial scans are scheduled in Edmonton on August 14th and we will receive the scan results on August 17th. We are holding VERY tight to Hope that the scans will show no new tumors, and shrinkage, or at least stabilization, of her multiple existing tumors. I will update the Web site with the scan results as soon as possible. In the meantime, please take care everyone and enjoy a wonderful summer.
With special caring thoughts and continued Hope,
Bonni

[Amanda]

Dear Bonnie,
I am sorry to hear that Brittany was so ill and ended up in the hospital
How is she feeling now? I am holding my breath along with you all about the results of her CT scan.
Though, I think all of the things we have all been praying for will come true with this new drug!
I hope with all my heart what I am feeling is right!
She is young and strong and positive and this from what everyone has told me makes a huge difference!

You are all in my heart and my prayers!

Amanda R

[Beth]

God bless Brittany. My son fared well on the reduced dose, it will help Brittany too.