Clinical Trial E5103

Yay Jenn!!!  Woohoo!!!!!!!!!!!

Onty, thanks for your perspective. I'm still undecided. I think you're right that I can get unblinded. I know someone else who did. I'll check out those suggestions for my neuopathy.

Here's a another confusing bit. My last MUGA I had to take twice. Long story, but they wanted a better read and changed the injection protocol for 2nd try. My initial read was 49, but goes down to 45 with 2nd try. This all happenes within the span of a week. 

I don't have a clinical trial nurse - my PA acts as you describe, Kari. She's okay, but hasn't given me good info on Avastin. I had 4 A/C and 8 T (missed 1 when I was in hospital). I have 3 more T to go, and unblinded with Avastin on Friday.  I may try to go back for a quick visit with my original onc at Northwestern for one last opinion.

Which leads me to Onty's question. I switched oncs just before I started the trial, but checked that it would be okay to switch back mid-stream, so I'm pretty sure #2 is okay. Both offered the trial. I work in Chicago during the week, and commute 90 miles home to a small town in Michigan. Traded off the university hospital for convenience of local treatment.

My clinical trial nurse, Carol, is like Kari and Jenn's. She is absolutely wonderful! There for me always with answers, support, whatever I need. She is just awesome and I'm not sure I would have made it without her.

Michelle- Were you unblinded today? Which arm were you in?

I had my post-chemo ECHO this week. Ejection fraction was 55%. No change from the last one, so I guess it was 55% also. I couldn't find the results in my papers from that one. My EKG was normal.

I hope everybody is doing well. For those of you still in treatment, know that we are out here cheering you on!!

Just got back from Taxol #4 w/Avastin-Placebo.  I'm curious to see if some the SE's I was having during AC and Taxol #1 that have gotten better begin to return again.  My bloody sinuses have gotten much better, my dry mouth and sinuses weren't as painful and I have a sore that wouldn't heal that has almost completely healed.  With that said I am hoarse again this afternoon, but not sure if it's a bad allergy day or the drugs.

TexasRose - My Aunt lives in Texas and we've visited several times and I just love it there.  I'm glad to hear there were no changes on your scan. 

Hope everyone is feeling good today - TGIF!

TexasRose - My Aunt lives in Garland, which is where I stayed for a few weeks after Katrina until my job was able to place me elsewhere.  We temporarily placed my daughter in school during that time to give her normalcy and were embraced by everyone at the school, veterniary clinic (for my dogs), neighbors and so on. Of course, we've gone to visit for the Texas State fair - which is so much fun.  I had plans to visit this year, but.......... life didn't let it happen - hoping to head over next year.   There have been changes since 05 here, but I feel like it's coming back. 

Jenn- I hear ya- a lot of plans I had for this year didn't happen. I hate how cancer took over my whole life. Someday, I would love to go back to New Orleans. I thought it was an amazing place.

Onty- No, she didn't do my chemo. I met with her prior to chemo and we discussed my side effects and lab results, but the chemo nurses did the actual infusions. She always came and visited with me during my treatments though. She would sit and chat with me, my mom and my sister. Depending on how long I was there, she would come by more than once to check on me.

Dear Brena,

The trial is not closed. New enrollment is suspended. Sorry I need to correct your statement.

The trial's data safety board is expected to:

1. Review the 6 cases of CHF out of first 200 patients in detail

2. Monitor for developments in the next few cases, I am guessing 200

3. Ask Roche to make proposals for minimizing risk

4. Determine appropriate next steps.

The next steps may very well be:

1. What they did with a Phase III trial for Avastin for colorectal cancer. The trial enrollment was restarted with added cardiac monitoring program i.e. more frequent EKG/MUGA.

2. Closing/cancellation of the trial

Somehow I doubt that the trial will be closed/cancelled. In talking to some oncologists I have come to believe that the 3-4% risk of developing CHF was known from other studies and they all view this as a very useful and well designed trial.

Love,

Dear Michelle,

This is a tough call made tougher. Ask your onco and cardio to give you their recommendation and then ask them if they would give the same advice to their sister if she were in your shoes.

I am guessing they will want you to decide. Some questions that might help you decide. How much of a risk taker are you? Which of the 3 decisions (stop now, take 1 more dose only or continue in arm D) would leave you most satisfied in the long run no matter what we learn later?  Can your onco give you something to strengthen your heart while you are getting Avastin? What are your risks of MI if the LVEF goes to or below 40?

I'm also guessing that if you press them, they would recommend you drop out of the study now or after 1 more dose. I'd take the 1 last dose. After all, we know the cardio side effects of Avastin. We don't really know its benefit. But I'm not you.....

Good luck  deciding and please let us know what you decide and why. This could help others in the same shoes in future.

Michelle, the advice of the other gals is right on.  Let us know what you decide.  Big hugs

Unk -  In addition to the scans done as per the protocol,  I did have an additional EKG and Echocardiogram done via the ER because I was having a rapid heart beat, which have stopped since I've switched to Taxol.  I was told that the ECG is a good indicator of how the heart muscle is working, blood flow, etc.  However, this is all new to me and I am still learning, but I do feel comfortable with the testing I've gotten so far and don't feel the need to push for additional test.  If you are concerned or having any reason to believe you may need additional testing because of symptoms from rapid heart beat, increased blood pressure to shortness of breath I was told that the onc can order additional test and they should be covered by insurance.

I had Taxol #4 w/Avastin-Placebo Friday and noticed that my bloody sinuses, cactus butt and extra tenderness around my (healed) incisions are back.  I don't know if it's mental or the Avastin, but am really curious to find out. 

Kari  -- So glad to hear the tongue thing is gone, now you can eat food and actually taste it and not have discomfort. Thanks for the encouragement - today is the day I needed it - THANKS!

Some great advice. I've posed the "what would you do if it was your wife/mom?" and will do again. Unfortunately, my onc and cardiologist are not in close proximity, so I can't arrange the joint meeting. My cardiologist's advice was to take the last treatment, then press my onc to supply some really good reasons for continuing. She also ordered another echo but said we go by the LVEF of the MUGA, it's more precise. With my numbers study protocol just calls for me to be more closely monitored.

Onty, I had red flags before this started, so don't let my results scare you. Remember I had chest radiation at 13 and have been followed for years by a cardiologist for moderate mitral valve regurg and borderline tachycardia. Your numbers sound completely normal. I'd just go with the flow on the MUGA since it's more precise - but that's just my take. 

I am a bit of a risk taker, but a calculated risk taker, and I'm just not feeling comfortable with these numbers. I'm living with the after effects of aggressive cancer treatment (i.e. my BC from chest radiation) and think I would have a hard time with myself if this gets worse. And I'm 90 pct ER/PR positive, so I do have more bullets. I'm still leading toward pulling out, but will let you all know on Friday.

Michelle

Gosh, I haven't been looking at my UPC numbers. My cardiologist just commented that my kidneys look great, and I said, "Well, thank you" (I didn't know what else to say) and she laughed.

Unk - I'm looking at my reports and the ranges considered normal are:

Creatinine, Urine is 15-325  (my last one was 151)

Protein, Creatinine Rat .05 -1.07 (my last one was .08)

Urine Random- Te report didn't give me the normal range, but mine was 12 and I was told it was normal.

I know we're both still in the midst of the trial, but it looks like the numbers are normal.