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Pazopanib vs Placebo 54 week study

ejones_pa's picture
ejones_pa
Posts: 8
Joined: Mar 2012

Anyone else in the Pazopanib 54 week study. I am sure I am doing the right thing by entering the study. At least I am being watched closely. I have not had any real side affects so does that mean I am on the placebo? My husband seems to think that just because there are side affects it doesnt mean I will have them. Thoughts???? I am 15 weeks in and last scans were good. April scan showed a small nodule where the right kidney used to be, May scan showed it was no longer there? Was it the drug or just an inflamation that was absorbed? Next set of scans are scheduled for mid September my 20th week !

On my last visit June 20th they found that I am Hyperthyroid, just another blip in the road. Getting an uptake scan to find out the next step. This makes you feel just miserable ! Ups and downs. Wizard put me on a low dose Klodopin. I really resisted but think it was the best move for me to take the drug.

Just checking how anyone else is with Pazopanib???? Thanks, Edna

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

Hi Edna,

John, my husband, is on Votrient and he has not experienced any severe side effects. His thyroid numbers have been up and down since starting his trial of MDX 1106 (also called BMS936558) and Votrient, but we can't say it's due to one of the drugs, both of the drugs, or totally unrelated to the drugs. But overall, he's had a 42% decrease in tumor burden (12 weeks).

Since you had a nodule and it's now gone, let's believe you're on the actual Panzopanib and it's doing what it should be.

Good luck to you on this trial. Be sure to provide feedback. Panzopanib/Votrient is a hot topic right now with lots of people coming to this Board wanting to know what to expect. You can be a big asset in providing feedback.

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

Edna, are you sure you were found to be hyperthyroid and not hypothyroid?

The posology of Votrient admin seems to be a work in progress but a known side-effect is hypothyroidism so, Alice, my guess is that John's fluctuating thyroid numbers are ascribable to the drug (BWDIK). The following info. on the drug (from GSK) is significant:

"In clinical studies with pazopanib, events of hypothyroidism have occurred (see section 4.8). Baseline laboratory measurement of thyroid function is recommended and patients with hypothyroidism should be treated as per standard medical practice prior to the start of pazopanib treatment. All patients should be observed closely for signs and symptoms of thyroid dysfunction on pazopanib treatment. Laboratory monitoring of thyroid function should be performed periodically and managed as per standard medical practice."

ejones_pa's picture
ejones_pa
Posts: 8
Joined: Mar 2012

Hi Tex, yes it is HypERthyroid (graves vs hashimotos for hypOthyroid).....going for an uptake scan on 8/23.....had to wait since other things got in the way. I will deal with the ups and downs until then.

ejones_pa's picture
ejones_pa
Posts: 8
Joined: Mar 2012

Hi Alice, Is your husband also in a trial? Or on actual medication? I flip flop back and forth as to if I am on the actual Pazopanib...600 MG I had no issues other than feeling cold all the time, then when they increased to 800 MG all heck started to break loose. So is my mind playing tricks or am I really having side affects.

Is it just coincidental that my thyroid acted up? Wizard does not feel that thyroid is one of the side affects. Anyway trying to keep positive and keep my mood in check and live life...thanks for answering and good luck with your journey....

I AM STRONGER THAN CANCER ! ! !

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

Thanks for clarifying that Edna. You've made me think a bit more - my Wife has trouble keeping the right level of medication for hypothyroidism and it seems as if thyroid problems often have one on a knife edge; it certainly affects her energy levels dramatically.

Unless your variations are very wide, being hyperthyroid might play well into Votrient treatment?

Raine22's picture
Raine22
Posts: 31
Joined: Jun 2012

Hi Edna. I am starting week 12 on the trial so I am a little behind you! I feel very fortunate to be in the study, but the "not knowing" if I am on the real drug or the placebo sure can play tricks on your mind! Some days I think I should throw in the towel and get out of the study just to quit the worrying!!
I increased from 600 to 800 mg 3 weeks ago.

My liver enzymes (Alt) were increasing every visit. At 8 weeks, they suddenly dropped from 108 to 37. They were afraid they wouldn't be able to increase the dosage and were very, very surprised that the numbers decreased so suddenly. I worried and worried about the liver enzymes and why they were increasing. Now my thyroid numbers are jumping around, where my T4 is down and TSH is up, which would indicate signs of hypothyroidism - at least if I read everything correctly! They are going to monitor the thyroid very closely.

I have some sleeping medication since I have insomnia. I occasionally take anti-anxiety meds. My whole world changed in a single day in March, as I'm sure it did to you at some point.

I know that liver issues, thyroid issues, blood pressure, etc, are all side effects. I have extremely low blood pressure to begin with but it has really stayed low, only going above 100 one time since I started the study. I don't have any hand-foot syndrome problems, but feel as though my toenails want to peel backwards!! Ive had horrible mouth sores twice, then I wake up and they are gone. I haven't seem to have lost any hair, and if it's changing to white, its hard to tell since I've colored it for so long, that I don't know how much gray I already had!!! About once a week I find myself completely exhausted, but not sure if it's physical or mental or a combination of both! But I let myself have the day and do next to nothing. It's sorta like a "self-recharge"!

Bottom line is that I may never know if I was in the study (at least what I was told), and all I can do at this point is pray that I am on the real drug and get on with my life! I have done nothing much but worry since March. I have 3 daughters and a husband and I need to get on down the road and quit feeling sorry for myself and worrying!

I am seeing a therapist and he has convinced me to just believe that I am on the real medicine and that it is doing great things for me. If I seem to have side effects, great! If I don't have them, great! Pretty simple yet great advice!!

Keep me posted on your visits and I will do the same! Good luck!

Raine22's picture
Raine22
Posts: 31
Joined: Jun 2012

Hi Edna. I am starting week 12 on the trial so I am a little behind you! I feel very fortunate to be in the study, but the "not knowing" if I am on the real drug or the placebo sure can play tricks on your mind! Some days I think I should throw in the towel and get out of the study just to quit the worrying!!
I increased from 600 to 800 mg 3 weeks ago.

My liver enzymes (Alt) were increasing every visit. At 8 weeks, they suddenly dropped from 108 to 37. They were afraid they wouldn't be able to increase the dosage and were very, very surprised that the numbers decreased so suddenly. I worried and worried about the liver enzymes and why they were increasing. Now my thyroid numbers are jumping around, where my T4 is down and TSH is up, which would indicate signs of hypothyroidism - at least if I read everything correctly! They are going to monitor the thyroid very closely.

I have some sleeping medication since I have insomnia. I occasionally take anti-anxiety meds. My whole world changed in a single day in March, as I'm sure it did to you at some point.

I know that liver issues, thyroid issues, blood pressure, etc, are all side effects. I have extremely low blood pressure to begin with but it has really stayed low, only going above 100 one time since I started the study. I don't have any hand-foot syndrome problems, but feel as though my toenails want to peel backwards!! Ive had horrible mouth sores twice, then I wake up and they are gone. I haven't seem to have lost any hair, and if it's changing to white, its hard to tell since I've colored it for so long, that I don't know how much gray I already had!!! About once a week I find myself completely exhausted, but not sure if it's physical or mental or a combination of both! But I let myself have the day and do next to nothing. It's sorta like a "self-recharge"!

Bottom line is that I may never know if I was in the study (at least what I was told), and all I can do at this point is pray that I am on the real drug and get on with my life! I have done nothing much but worry since March. I have 3 daughters and a husband and I need to get on down the road and quit feeling sorry for myself and worrying!

I am seeing a therapist and he has convinced me to just believe that I am on the real medicine and that it is doing great things for me. If I seem to have side effects, great! If I don't have them, great! Pretty simple yet great advice!!

Keep me posted on your visits and I will do the same! Good luck!

ejones_pa's picture
ejones_pa
Posts: 8
Joined: Mar 2012

Hello Raine, I started my 54 week program 16 weeks ago this coming Friday. It has been a journey with very little side affects that are real(at least to me)Could I be lucky enugh to be on the drug and not sucumb to side effects? I too am one that thinks my mind is playing tricks on me. I never want this cancer to come back or any other cancer to show up.

I have read and re-read the list of side effects, sometimes my blood pressure is high, I have always been around 100/70 and have been as high as 140/90 since on the meds (?), but could it actually be white coat syndrome? They retake 3 times and it always settles down,(i think of the beach, waves and a beer in my hand) and tell them not to ask me questions ! lol

All of my labs have been great and within normal ranges since the beginning. It is just after the last visit that they found I was hypERthyroid, not a kown side effect of the drug. The wizard says this could just be something that happens to people. Oh lucky ME ! ! !

My last visit on June 20th, I just had a horrible week, ups and downs,cranky, tired just not myself. We thought that maybe it was just all the stress going on in my personal life plus the worry of cancer returning. He prescribed Klodopin .5mg twice a day, thinking my problem was emotional. Only to get the call on Monday telling me about the thyroid isue and get to my primary to get that under control.

I always thought my hair would be the tell tale sign, but like you i color my hair and would never know, although my hairdresser who I have gone to for years commented that my hair texture has changed? lol again is it growing older or my mind playing tricks.

So since I cannot be on thyroid medication until after the "uptake scan" so they get a true reading. I dont want to be on the Klodopin because I dont feel like myself. I am going to wing it until 8/23. Cross my fingers, spend time with family, pray a lot and hope for the best !

Thanks for listening.....all the best on your journey ! Post back on your progress and I will post on mine next week ! Good luck. Off for a much needed 5 day stay with my sisters to laugh and enjoy each others company ! So lucky to have them ! ! Hugs !

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

Edna, I hope your uptake scan proves helpful.

Given the importance of the issue, has anyone reported your hypertyroidism to GSK? It's a massive UK company but has huge worldwide presence, including the US of course. They may have heard of other cases like yours but not a sufficient number to draw any conclusions so far. Additional data could be valuable. As you'll have seen, hypothyroidism and hypertension are known risks but there is no reference to hyperthyroidism in the most recent and pretty comprehensive prescribing info. (April 2012 in the US)

http://us.gsk.com/products/assets/us_votrient.pdf

Your experience might give a heads-up to future patients even if "The wizard says this could just be something that happens to people."

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

Edna,

Yes, John is on a trial, a combination of BMS936558* and Votrient trial (*formerly MDX1106). John started on May 2, 2012. You'll note Tex is referring to my concern posted earlier about John's THS numbers. Even though his past three thyroid readings were low, they didn't discontinue the Synthroid (which was given to him after the May 2 high reading) until I questioned it.

I will say that he has been off the Synthroid for a little over a week now, and his energy level and overall stamina show a marked improvement. Coincidence--I don't know?

BTW, who is Wizard?

THS (normal 0.50 – 4.50 mg)
1/03/12 – 3.44
1/31/12 - 3.50
2/16/12 – 2.14
5/2/12 – 6.99 HIGH
5/10/12 – 4.21
5/31/12 – 2. 27
6/20/12 - 0.18 LOW
7/11/12 – 0.05 LOW
8/1/12 – 0.3 LOW

___________________________________________
Alice (caregiver for husband-John)
John – 63 Caucasian
Diagnosed: 10/14/11 Kidney cancer clear cell/grade 4/stage 4 – with sarcomatoid features and lung mets; also has soft tissue mass in shoulder area and pelvic area.
Symptoms: weight loss followed by cough
Surgeries: right nephrectomy - 11/1/11
Treatments to date:
January & February 2012 -HDIL2 treatment/first round 14 doses/2nd round 10 doses;
(discontinued after February 2012 as scan did not merit continuation)

5/10/2012 – BMS93558* Votrient trial (*formerly MDX1106)

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