Who has completed Phase I trials?

FloridaLady

(Sorry for my typing –very bad neuropathy)
I would like to know how many ladies have done Phase I or II drug trials. I would like to know your experiences good or bad. Here is my one disappointing but possibly not my last trial. (per my doc’s)

It was at MD Anderson Houston. (#2 in the world) starting in Jan 07. My local doc called with note that I have aggressive localized cancer. Took numerous phone calls and 3 months for an appt. My doc would not treat because it could limit me in trials. (You need to be off chemo’s so many days) Got to Houston and to see new doc. Gave me 15 minuites and offered me only one Phase I trial. Normally they give you at least two or more choices… you have to make choice yourself. And not all Phase I that only test toxicity. I had to make a choice that day. I was told I needed to stay in Houston 6 weeks?? (mostly for blood work? I think my local doc could handle that) They said that if I could tolerate the drug and stay in trial they would reimburse me for traveling expenses. ($8,000) This was the first lie of many. They told me do not tell your insurance co. that your doing trials. But if they don’t pay you are liable for the cost. (aroplatnium was free) (final cost 4 tx with no chemo $200,000. So far no questions from my insurance. (your scans are double the cost more than what they normally pay) I asked “Because they are a research hospital. EXCUSE ME..MY Insurance paid, they get grants and drug companies pays for trials. No one goes there for free. This is why most insurance co. don’t let you go there. This cost has only CT Scans, blood & office visit. You did not see your doc most visits …only “fellows”. (docs in training)

Well this was my only option. So I had CT Scans only. They would not do a PET. They asked numerous times what kind of cancer did I have?? They told me in the contract that I would have blood draws. Did not tell 28 in 8 hours. Total for 1st chemo 38 in two weeks. 2nd appt with doc…He did not know my name when he walked in the room. Got info than told me they did not see any cancer. Argued with me where it was than went and re-read scans. OK now on same page. Now I would need to wait 4 to 5 hours for the chemo to be mixed each trip. (monthly tx) Another lie...chemo was defrosted not mixed. They could do it that morning and if not used refreezed. Per my chemo nurse who always handle this trial. Who by the way told me to refuse all the blood draws if I could. They would not let me.

Ending was bad… cancer continued to spread, disabling neuropathy, high blood pressure & some hearing lost. I have taken 9 months of previous chemo’s (6 kinds) with very little side effects. Worst part I found out they gave me a large dose 250 mg verses 180mg. They knew was the tolerable level. This was approved 3 weeks later at the 180mg. So they knew what was way too much already. I later research online found Germany already did study and found it not a good drug. Five years ago! They have never followed up with me…I was a very healthy person with a little cancer…now I’m unhealthy person with less cancer because I convinced my local doc for my surgery.

Would I do it again??? Not without heavy thought and prayer. I did think of all you ladies and thought I might help you one day.


Lesson learned and to pass on.
Get everything in writing. You sign a contract that says “they might pay traveling expenses.” Ask for the facts in writing.
Research the drug. Other countries use these drugs before we start testing.
Your doc in Phase I trials may know nothing about your kind of cancer. (mine was a skin doc)
Bigger is not better. My local center they are like family. I felt like a slab of meat.

Please let me know your story.

Living in Hope.

Indigoblue

My neuropathy is actually a disabiltiy at this point...just gets more difficult as time goes bu-bye.

Have not gone thru Trial anything, but 2 friends did; both had incredible treatment, surviveed and had the best treament available. One friend was even given transportation, prescriptions for pain, and given help to get her life, house, animals, and legal plans in place...she lived for 10 years and was 97 when she passed.
An artist, ceramics genius; wish she'd lived forever.

Indi Be well, be loved, hope rises as the sun sets moments of time, prismatic chroma, and tint telling mankind/womnkind...life is.

Each day is a never-endinv placment in the pictures of tine; the tine iw your life.

CalGal

FlaLady -

So sorry to hear about your horrible experience in a Phase I trial at MDA ... It sounds like you went into the trial with reasonable expectations for your own health and for helping others. My understanding is that Phase I trials are all about dosage.

As one with mets who does a lot of research, I've always held MDA in the highest regard as they seem the most pro-active for those of us with bc mets (among other things, over a year ago, I read about them doing radio-frequency ablation for liver mets - and my HMO denied me - but I kept pushing and finally got RFA!) ...

I'm in CA, but have always figured I'd end up at MDA for at least a consult at some point ... When I do, I'll be careful.

From your e-mail, I'm not sure your bad experience is due to MDA policy or specific doctors ...

Last week, I started a Phase II trial. No one offered it to me ... With research, I found it (in England and Australia and had to call the pharm co to find it in the US). I wanted to be in the trial so much. After initially being denied by the pharm co, the onc disagreed with that decision and went to bat for me! It's the PARP inhibitor trial (targeted therapy) .... you have to be BRCA positive and have mets. I'm fortunate that I only live 3 mi from the cancer center, so, I didn't even read anything about travel expenses, etc.

I hope you recover from the symptoms you've described.

CalGal