Clinical Trial E5103

brena · April 2008

brena · April 2008

Ladies,

I am looking to share symptoms (remedies) and information with other woman who are participating in this clinical trial:

"Double blind study phase 3 using Doxorubicin and Cyclophosphamide followed by Paclitaxel with Avastin or Placebo"

brena

sftfemme65 · April 2008

Hi I think thats the trial I'm on.

I took dose dense A/C with "maybe avastin"---every 2 weeks four times...now I'm taking Taxol weekly for 12 weeks and the "maybe avastin" every 3 weeks. I have 8 more taxols and 2 more avastins to go. I really think I'm getting the real stuff. I have nose bleeds and my voice is effected too.

So where are you at in your treatments? What stage are you?

Teresa

HeatherBLocklear · April 2008

Hi Brena and Teresa,

Although not in the same clinical trial as the two of you, I am nevertheless in one that also includes Avastin. I know I'm getting it because it is not a double-blind study. For that reason, I can give you the SEs of Avastin so that you might be able to judge if you're being given that drug or not.

Hoarse voice and bloody nose are absolutely signs of taking Avastin. Bone/body aches is another SE; so is headache and, in some cases, exfoliative dermatitis (redness and peeling of hands and feet). Dry eyes, mouth sores, and nose sores can be caused by Avastin; they can also be caused by a number of other chemotherapy drugs.

The most reliable indicator of getting Avastin is the bloody nose. Not necessary frank nosebleeds; in my case (and in that of others I've known), it's more like a stuffy nose that bleeds when blown.

Here's to recovery!

Annie

sftfemme65 · April 2008

Annie,

I definitely have the nose thing! I hate it lol. your lucky yours isnt a blind study, it's not fun knowing if your getting the real stuff or not.

I have a good feeling about the use of avastin and it keeping this nasty stuff from ever coming back for all of us!!!

Teresa

brena · April 2008

Hi Teresa and Annie,

It appears Teresa and I are in the same trial. I completed my 8th Paclitaxel shot on 03/28th and was scheduled for my 9th today but could not take due to SE's.

This is where I am looking for some help from someone else in the same trial having the same serious SE or anyone else having this experience. I have the same chemo regimen as Teresa, I am just further along on the Pac shots.

After 4th shot of Paclitaxel I developed a red rash on the top of both of my hands; from knuckles to wrist (rash does not itch.) Subsequent shots have now increased the rash to my elbows. I am trying many suggestions to reduce the rash but seems hopeless. The worst days of discomfort is the three days following the shot.

Then to add to the SE, after my 7th Paclitaxel shot I developed swelling and pain in both of my large toenails, they turned white and raised from the toe resulting in an infection in both feet. Additional toenails have turned white and some pink. Today I can now move most toes and swelling is gone, due to taking antibiotics? but the toenails are still sensitive but getting better. Doc skipped this weeks session to give body chance to recover, it seems these SE's increase with each additional session.

On their own each Paclitaxel and Avastin present their own SE and can be identified of which my SE's is not listed. Does anyone know what SE when they are given at the same time?

I am assuming that I am receiving Avastin (double blind study.)

Please let me know if you experience either the toenail or red rash SE. I do have the nosebleed, increasing BP and hoarseness in the voice.

many thanks

sftfemme65 · April 2008

so far my toenails are ok...hope they stay that way. My fingernails hurt but thats all. My bp has remained the same. I have lots of nose bleeds. In fact everyday, but its liveable. I do have a hoarse voice the week after treatment. That rash has been the strangest thing. Mine has actually gotten better and I hope it stays that way.

Teresa

brena · April 2008

Ladies,

Check out the "triple negative" section for more talk on this trial.

smiles

carolynf · April 2008

Hi all,

Annie, I am glad to hear that your study is not like ours w/being blinded. I have the nosebleeds or should i say every time i blow my nose in the morning is when there's blood or the nose is bleeding. My voice is definitely hoarse. So with my 13yr old son and his voice changing its kinda funny. I hope this helps in the long run in determining what works best for treatments. Forgot about todays BP. It was high considering what i usually have and onc told me if its same next week we might have to do something about it. Hopefully this week the weather will break and i can get out and do some walking. Keeping the faith!

Carolyn

otter · April 2008

Hi, fellow sufferers--

I'm not in your group, but I am getting Taxotere (docetaxel), which is related to Paclitaxel. I'm on the TC regimen.

According to everything I've read, the SE's of taxanes include skin rash, peeling of skin on hands & feet (sounds like what Annie called "exfoliative dermatitis"), discoloration and/or detachment of fingernails & toenails, and muscle & joint aches and pains. My onco even mentioned the muscle pain from Taxotere as a disadvantage, compared with Adriamycin (my other option).

As Annie said, mouth sores and nose sores are common among a whole bunch of chemo protocols. I don't know how to sort all this out. One thing, though--I'm nearly to day 8 of my first TC cycle, and I've had no indication of a nosebleed. Y'all can have that one!

Hugs,

otter

brena · April 2008

Otter,

I don't think we are meant to sort out the SE from each drug just report them. How many cycles do you need to receive and at what frequency? You can expect to get some of the SE listed for your cocktail and just when you think you have them pegged they change (more or less.)

My two large toenails are probably going to need removed, hanging on for dear life! Fingernails have less pain since I had them trimmed really short (what an experience, pain-pain and more pain.) My first week for muscle pain as Carolyn is starting to experience.

Laughing

brena · April 2008

Carolyn & Teresa,

I would like to move our conversation to this section so it easier for future participants in this trial to find us and the information that we are sharing.

I overslept this morning, daughter woke me up and asked if I was getting my shot, (took a sleeping pill) won't complain because I have several months of sleep to catch up-on. I came home and slept several more hours, just plain tired! I am not usually this tired.

I was unblinded today, I was receiving the Placebo (Arm A.) Dissapointed but am still 1/3 of the contribution. Anyway, two more shots to go, May 2nd is the last shot!!!

My Liver Enzyme results were within normal range this time around, I did not ask about prior test results. Sugar level a little high but don't think it is of any concern. I continue to be healthy in every respect except a little breast cancer, would very much like to continue to stay that way minus the breast cancer.

Carolyn,

12 going on 21. Not sure which journey will be harder....cancer or raising the 12 year old daughter? Love every moment because they do not last very long.

Teresa,

Do you have any children? if so what ages?

still tired,

take care

sftfemme65 · April 2008

Brena,

Thanks for posting so quickly about your results, I thought about you several times today. I'm surprised you weren't receiving the avastin, you seemed to have alot of the side effects. I hope your not too disappointed.

I have 5 children, my son is 25 and my daughters are 22,21,20,17.

Well, my hair is falling out again. It just started a couple days ago. I'm so disappointed, I thought maybe it would keep growing. My onc warned me it would probably happen.

Teresa

carolynf · April 2008

Good morning,

I had been cking the posts yesterday to see if you had posted your results. I agree that even though you were given a placebo, you contributed to this cause. Monday is my day and its the LONG day because I receive the extra trial drug. Teresa, I can see why your hair is falling out...5 kids! Laughing I have 3 and it gets zooey around here and they are much younger (9,12,13). BUT i grew up in a family of 5 kids and it was the best and still is. They are a HUGE support group. My older brother is reading books on irradicating cancer thru herbs and eating etc. He's on his 4th book and calls me almost daily to give me a breakdown. I even get information from my older sister in Iraq who keeps sending me funky scarfs/hats.

Onto hair, mine is still coming in. I am still unsure if it will stay or go. Is your head hurting like it did when your hair fell out the first time? My kids tell me its growing fast but I really don't want to get to attached incase it changes once chemo is done. I can say that I have been more tired this last week. Not sure if that's how you are feeling Brena. Somewhere in my mind I thought someone told me the last 3 wks are when/if you will be very fatigued. I left work early Thursday and came home and slept for 3 hours and then cooked dinner, ate, and lounged. I don't know what its like to stay up past 9pm anymore. Well, I need to go food shopping since it was a wash this week. I need to stop at my moms so she can go w/me. She has been the one to take me to chemo mostly. My husband has a hard time sitting there watching me get up and down w/jittery legs that he thinks i'll pull the needle out...I like the girl time w/my mom. You ladies take care and I know we will be thru this soon and moving onto the next phase. Wish me luck on my enzymes on Monday.

Carolyn

brena · April 2008

Teresa,

Was disappointed or maybe more surprised to be receiving arm A. Your symptoms and mine are more similar than compared to Carolyn's symptoms. I feel there are now more questions around some of my symptoms that are not caused by Paclitxel.

Teresa and Carolyn,

When you are unblinded ask what sequence number you are, the number you were assigned when you were registered. I was number 5.

Also, when you are unblinded the letter E must be put in front of the trial number otherwise the program will not unblind you.Example: E5103.

I was told the unblinding process was time consuming so whoever is performing this might need a heads-up.

Since I missed one week of Paclitaxel and a 20% reduction this last week (and the remaining two cycles) the rash is more of a slight pink than bright red. The test will be when I revealute the rash at the end of next week, usually its worse the closer I get to the next shot.

I am taking a cruise from NY to Bermuda for a week, my sister is flying in from Texas and we will be going together. I can't wait! We will be celebrating completion of my chemo in addition my birthday that Wednesday. I think even with being bald, minus two toenails and a rash on my hands I will be able to enjoy myself.

I asked and am not allowed to tan, even went as far to say STAY out of the sun and wear a big hat due to pigment of skin and my current rash.

I will take sunblock and a hat because I am not sure how I would stay out of the sun in Bermuda?

brena

beautiful day and will soon be heading out for my daily bike ride (my time) Cool

brena · April 2008

Teresa,

I had to LOL when you said your hair was again falling out, made me feel good........sorry. At best I have little white stubs that can only be felt (or seen with a magnifying glass) as my kids rub my head at times when they walk past me as if I was a Buddha or it gave them good luck!

Advantage: I drove with the car windows down and did not have to worry about hair flying in my face Laughing

brena

sftfemme65 · April 2008

Brena,

Thanks for the heads up on the unblinding process. I am beginning to now wonder if I am receiving the real stuff too, since you and I have similiar SE's. On thing that is really bothering me now is my fingernails and toe nails. Then just ache so much now. My fingernails on about half of them have red streaks. Thats weird isn't it. I'm going to show the doctor tomorrow. My nosebleeds have gotten worse. Its driving me nuts.

I wish I could blame my hair loss on the kids, carolyn..lol. But since only one is left at home I can't. I really am surprised my hair fell out again....Doesn't look like I'm going to have much for summer. I will need to stock up on sunblock for sure.

Teresa

brena · April 2008

Carolyn,

Got my fingers crossed for your unblinding tomorrow and good luck with good Liver enzyme results.

I still feel like I want to sleep more frequently, I think some of being tired is due to my allergies (meds not working that great.) Make sure you get plenty of rest........listen to the body! From someone who doesn't.

Do you know when you will be starting rads? I am pushing mine out to 6 weeks, that is the maximum allowed per our protocol. So I have to start rads by June 9th; although wishing I could skip the entire process. I will be taking 8 weeks off from work for the radiation process.

I believe your Onc attended a meeting in DC on this trial? if my memory serves me correctly he is returning this week, if so pass along any good information that might help the rest of us. Don't forget to ask what sequence number you were assigned.

take care,

brena

brena · April 2008

Teresa,

Sorry to hear your fingers and toes are feeling worse, definitely have them looked at by the Onc. Someone else is having a difficult time with the nose bleeds, there are some suggestions posted under the Triple Negative see Taxol side effects. Maybe some of the suggestions might help you. My nose does not bleed that often freely, always when I blow my nose even if so gently.

It appears I have some side effects that are caused by the Paclitaxel, SE's are very similar to the Avastin SE's. The red rash on the hands is the bigger mystery, my rash has turned brighter red since my last shot.

What date is your unblinding?

smiles,

brena

carolynf · April 2008

Hi Brena,

I am getting ready to go to my appt at 9am. I am axious to say the least. I had softball practice from 3-5:30 last night and all the other coaches were saying you can leave if your tired, etc. To tell you the truth it felt great to be outside (not at first). Once we set up stations for the girls and I was working on batting the time flew by and my mind was off my issues and onto getting these girls ready for the season. My onc says that i won't start rads for another month after my last treatment. My estimation date would be around June 5th timeframe. I am going on military training starting May 13th to Cape Cod and then coming back playing war games. My commander was concerned if I was going or not (I am the people person and work directly for the commander so when issues/problems arise it is I who deals w/them). I am looking forward to it. We do have some fun. Plus, I am doing am running a powerpoint on military etiquette w/some other things thrown in there. So I won't have to jump in a foxhole and shoot my M-16, even though I look forward to it. A lot of my training will be put on hold because of not enough time/space. I do try to take ME time and rest. I am forcing my husband to go to a back specialist instead of Chiro. because his back has gotten worse. So he's my other one to worry about but if i can get him in then it will alleviate some things in life. Well, my moms here to pick me up. I will ask about the meeting he went to and try to get my sequence number. Will email later.

Carolyn

carolynf · April 2008

Good afternoon ladies,

Well i was unblinded today. I am/was in Arm C. So my onc told me to think about being in Arm D. I am happy that I did receive the trial drug and talked w/my mom in regards to continuing. I feel it won't be as bad as chemo, less se's. My husband is hestitant in me continuing because of the port not being able to draw blood. So we will talk tonight. Because of my onc was having a hard time using his ID etc i totally forgot to ask about the sequence number. I will make a note for next week to ask that question. In regards to the meeting that I thought he attended, was a year ago. I guess i am really losing my hearing and getting chemo brain badly. I will continue on w/my rads in June. No date set yet. Next week will probably talk about setting up my appts at the other cancer center for that. My liver enzymes were just 4 pts above normal. He thinks it maybe the avastin that increases the enzymes. Well, I need to get things together due to a softball practice and baseball practice tonight. Might get a nap in before! BTW, my onc had 1 person in the phase 2 trial but looks like I am the only one for this phase at least at my location. Brena, have a wonderful time in Bermuda...YOU definitely deserve it. Remember that some men think bald women are sexy! At least that's what I've been told. I wish I could be sailing w/you. Teresa, am still looking forward to you being unblinded. It will be here before you know it.

Cheers,

Carolyn

sftfemme65 · April 2008

Congrats on receiving the avastin, Carolyn. I am going to hate waiting a whole 3 weeks to find out. I am so worried that I didn't get it, since I thought the side effects can be from taxol too. Did you have any blood pressure problems, I didn't. Anyways my nailbeds are going to probably get worse before better dr says. He thinks I will loose a nail or two. great. MY treatment went ok today, I had a great nap..lol. If you decide to do the extra 10 when will you start?

Teresa

carolynf · April 2008

Hi Teresa,

My bp has gone up a little nothing high at this time. I can't remember if I told you I had bleeding gums 1 or 2xs. Today after receiving the avastin i got a bloody nose when i got home. My nails are looking pretty ugly (thumb and pointer finger). I know they will grow out but in the meantime will deal w/it. I already have an appt to start the avastin Arm D on May 12th. I figure i will complete it in December. The only thing I worry about is the liver enzymes. It was 4pts over today. No big deal. My onc figured i was on the drug because of the way my liver reacted the week after receiving avastin. It would be elevated. I can't believe you and Brena nap during treatment. I have to get up and move around! My legs want to go, go , go. The one thing about going on the next arm is that you can't have any surgeries due to bleeding which is kinda scary in case something happens.... got to stay positive. Well, time for me to go to bed since i have to work tomorrow.

til then,

Carolyn

brena · April 2008

Carolyn,

Ya hooooooooo!!! Congrats and am so excited for you and hope you decide to move arm D. Your port definitely needs to be working properly, are you getting your drugs through your IV? and are having problems with blood being drawn from it? Are your surgeon and Onc aware of your problem with your port?

You leave for your training on May 13th, when do you return? remember to take care of yourself. Which of your children play girls softball?

Has your hubby visited the back specialist? back pain is one of the more difficult pains to deal with almost none functional.

have a great week & keep in touch

brena

brena · April 2008

Teresa,

Hang on and don't jump ship on us, you can very well be receiving Avastin remember the symptoms are very similar. Receiving or not receiving Avastin in no way affects your current treatment you are receiving against your BC. Deep breath!!! Your unblinding will be your 8th cycle, is that May 5th?

Are the nail beds loose on the toes or fingers or both? Speaking from experience, missing two large toenails are much easier to hide than missing fingernails. Now the bald head...well you get the idea.

How are the nose bleeds? any concerns from your Onc or suggestion on reducing their occurrence?

sleep well,

brena

sftfemme65 · April 2008

Brena,

Nosebleeds are daily but my counts are fine so I'm not too worried about them, neither is anyone else I guess. I know I shouldn't worry too much. Its already been decided basically. Its just with me having 3 positive nodes, I'm scared sometimes more than just a little.

so far the nails all look and feel secure they just hurt and look ugly.

I am unblinded on May 12th, I had treatment with the maybe avastin today (#7)

Have a great week everyone

Teresa

carolynf · April 2008

Hi Brena,

My port is working fine for getting my infusion, it just won't let them pull the blood for the labs. As long as i can get my infusion thru there I am fine. My onc says we will watch the port to make sure there's no clots that are binding around the flapper thing. I've had some pain up in my shoulder but i feel that could be due to the tubes in the power port are not as pliable as in a regular port. Some reading i've done to educate myself. Don't want to get it thru the veins. My daughter, the middle child inbetween 2 boys plays on the rec team and was picked for all stars last year but her birthday fell 2 wks late of age for playing. This yr she will have no problems.

Hubby had paperwork faxed over to an orthopedic back surgeon and then had to pick up xrays from hospital yesterday. Today he drops off xrays and hopefully gets an appt. He still has to hook up w/a hand surgeon to because he tried riding his other Harley and he had trouble w/the clutch. I broke my middle finger playing softball a few years ago and it took me a while before i could ride my HD. Hopefully he can get all this medical stuff squared away soon. He's suppose to ride out to Milwaukee for the 105th w/the guys in August. Hopefully he'll have his Street Glide back for that! Enjoy the sunshine before the cold weather returns....

Carolyn

brena · April 2008

Carolyn,

Glad to hear your not taking your chemo through your veins, what a mess that would be. Hope the port holds for drawing your blood and iv's.

Your daughter should be proud for being picked for the all stars, tough competition. Wish her luck and a great season with much fun.

I am a fan of soccer, coached my daughter's team for several years and loved every bit of it. It definitely required time and patience especially for those parents, many times I wish they would drop their kids and go home.

Sorry to hear your hubby's back is not on the mend, maybe he will have a quicker recovery with the back surgeon. He definitely wants to be ready to ride in August.

You are bringing back memories for me, I also still hold a mc license. Rode a Hugger HD for several years, first bike designed for a woman (well balanced.) Times were great and those we rode with always made the ride interesting and a little crazy to say the least.

I eventually traded my bike in for my son, at times I think I should of kept the bike. I havn't rode in years, but the sound of a HD always turns my head. I guess its in the blood.

My hands are returning to bright red and are a little swollen, feet much better even got shoes on today. Feeling like crap this week, kinda like flu not sure why. I have been taking over the counter meds to see if it helps, not so far but will keep pushing forward.

I had my BC support group meeting last night, great as always. Great bunch of ladies from newbies to oldies, they share their experience and give suggestions and most of all just listen. We meet every three months and it does help to be in a group of those similar, hate to share to much info with family as they worry enough. There are times I hit the emotional roller coaster and for those that are in the same situation know not to take me serious, just listen-pat me on the back and move on.

BERMUDA....BERMUDA....BERMUDA etc etc and etc.

good night,

brena

carolynf · April 2008

Good afternoon all,

Brena, I am still receiving chemo thru port just my labs for blood are thru my arm. I am right w/you on coaching. I have coached both soccer, tball, softball for 8 years. My asst coach got pink shirts w/our team name on them and had the bc symbol put on the sleeve w/my name on it. I hope not to break down and cry at the first game they wear them...I did the opposite than you on the bike. My husband bought a new bike and gave me his old one. I didn't have a license and decided that I would get one so I could take off and have some ME time. Riding is definitely in the blood!!

I haven't hopped on the bike yet. Thought about it today. There's a little bit of a wind but the sun is out. I do enjoy my bike. I just don't know if I have the energy for a long ride. I might cruise downtown and back just to get in the saddle.

I am glad to hear your hands/feet are doing better. I have a toenail that feels like it was cut to short but hasn't been. So i am wearing sandles to keep toes free. Monday will be #11..YEAH! I just want to get done w/Taxol. I think that's the drug that's doing the majority of the se's. I talked w/a friend whose on avastin for her tumor on her kidney and she feels wonderful. She sounds wonderful. Well, it's a beautiful day and i need to go out and enjoy it. I hear you counting down to Bermuda!! I know you will enjoy it and will help heal the body and soul. Take care.

Carolyn

carolynf · April 2008

Hi all,

Brena/Teresa, had my 11th Taxol....1 more to go. Found out my sequence number was 6. My WBC was low and he wants me to watch for any signs of fever. If I have any, to go to ER. He hasn't said this to me before so it made me a little nervous. There's no way to get your WBC up. Maybe shitake mushrooms???? I am coaching Softball and you know the kids come down w/the darnest things. I skipped ball practice tonight since it was indoors, more of a threat there than outside. I was quite exhausted after treatment. We decided to automatically draw blood from my arm to do labs. After that came back and she went to do my port, when she drew back she got blood return. So next week we will try the port instead of the arm. That was enlightning.

Brena, do you have a start date for rads? I am calling my rad onc tomorrow to see when he wants me to get tattooed. I gather my start date to be sometime in beginning of June. Will keep you posted.

Teresa, 2 weeks to go to be unblinded?? Hang in there. It will be here before you know it.

Annie, How long have you been on Avastin?

Well, my eyes are sinking slowly. Time to retire to bed.

Take care all,

Carolyn

brena · April 2008

Carolyn,

Sorry to hear your WBC is low, rest and eat healthy and if someone coughs run the other way.......fast!

Glad to hear your port is functioning as it should be. Will you be able to do your rads daily and still help the commander with duties?

Not sure on doing rads, need to ask rad onc more supporting data for doing the rads.

Such as what will it decrease my local recurrence from % to %?
What will rads increase my overall survival by %?

note: all the supporting data that I can find on the web indicates rads is standard practice but with us being high risk/triple negative we should benefit more. Not sure if it is old data so I want to ask the rad onc for the most up-to-date data to make my final decision.

Let me know what your follow-up care consist of beside your visit for your Avastin shot.

According to our protocol we should start rad within 6 weeks of completing chemo. If I do rads I will try to push the time limit to the max and wait until the beginning of the 7th week for personal reasons-June 16th. Still a long ways off.

I get my last taxel shot this Friday, and one week off then to Bermuda. Return from Bermuda to have a HUGE family gathering, return to work and still get ready for my next protocol S0307 (not sure what prior tests need to be performed.) Must start within 8 weeks of completing chemo. See rads are even on the to-do list, maybe I will add it after Bermuda depending on what information the rad onc can provide.

Anyway, I just can't seem to get my head in gear for the rads, I did have the consultation last December and I still have my questions & notes. Maybe no-one will miss me if I don't go.......only kidding. Ok I will stop whinnnnning about it.

We havn't heard from Teresa in a while, I sure do hope all is well and she is just busy.

keep in touch and stay healthy!!

brena

Clinical Trial E5103

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