Taking part in drugs trials

I signed up for the TACT trial in 2001 and was a member of the control group. We underwent 8 cycles of standard chemotherapy (FEC) while the experimental group had four cycles of taxotere followed by four cycles of standard chemotherapy.

The preliminary TACT trial results have recently been released at the annual San Antonio Breast Cancer Conference. I have tried many times to find some information about them but can only find an abstract of the paper that was to be delivered on December 16th.

I feel very strongly that we the patients who agree to take part in these trials are treated very cavalierly by the medical establishment. Taking part in these trials is sometimes detrimental of our health. I know a lot more about the effects of this treatment than I did when I was a newly diagnosed patient who could barely take in what had happened to me and I certainly have some regrets about having gone on this trial - my chemotherapy lasted six weeks longer than it should have done. I also had an individual reaction to the anti-emetic medication which adversely affected my mental health. On the other hand we are doing our bit for research.
So why are we left in the dark?

At my last check-up the consultant told me that he knew the results but was unable to divulge them (as he put it).

Why can’t we be informed? a summary of the results would be fine.
If we didn’t take part there would be no trials.
:

I agree with you.

I found a news report of the SABCC which said

“Adding docetaxel to standard anthracycline-based adjuvant therapy failed to increase disease-free or overall survival in women with early-stage invasive breast cancer but was more toxic, according to data from the randomized phase 3 Taxotere as Adjuvant Chemotherapy (TACT) trial”

but if I post a link or even tell you the site, it will be removed by the moderator. I googled the string tact trial chemotherapy breast cancer preliminary results and it was the 4th hit (and there are a couple more below reporting the same - various US doctor sites.

I think we should be encouraged to find out about trials and have informed consent. I discovered sentinel node biopsy hadn’t finished being trialled yet my hospital had already introduced a substandard variety of it - only using the dye, not the dye plus radioactive tracer. I felt I should have had it explained that it was still on trial before I signed consent to have it. I am glad I didn’t have any other trials, especially after the disastrous events to those young men in 2006 or 2007 who took an experimental drug. I told my oncologist in 2004 that I wasn’t prepared to take part in any trials as the non standard treatment might not be better than the new one. I know we need randomised controlled trials of drugs to make progress, but I think they should try these things out on animals first, make sure we are not asked to take part at vulnerable times of our lives and be prepared to be completely upfront with us that the outcome may not be as good or better than the standard treatment.

Mole

I believe taking part in a clinical trial should be personal choice, and yes it should be a choice.
Potentilla, pls could you check the date of the paper you have received the results from. I have found conflicting results…however, there seems to have been quite a number of clinical trials so not sure if I have found the right one!
Regards, A.

mjmaam

I consented to a drug trial for Crohn’s way back in the early 80’s at the Hammersmith Hospital in London. I was told I would not get the results of the trial, but felt that was the only alternative was steroids, I should be proactive. I cannot for the life of me even remember the name of the drug, because it just had letters and numbers. I luckily had no adverse effects, but the trial was abandoned after 4 months due to other patients suffering severe problems. My gastro then, did not explain what they were, and I was too naive to even think about asking.

I had 6 x FEC chemo, in 2003, so I agree you most likely had an overdose.

Like Mole, I do not think I would ever subject myself to a bc trial.

Liz.

I have already been on two BC clinical trials and would seriously consider participating in future trials (as the clinical investigation ward at my hospital already knows). As a secondary cancer patient, I think many of us are more than keen to do this, as we are only too aware of the limited options available to us.

I doubt many of the full reports/digests from San Antonio are available on the web yet. Judging by previous years, some results are published quickly, some take months to appear.

Jenny.

andreaN - it’s a specialist press report dated 18 December 2007 from the SABCS, referring to the presentation made on 16 December by Paul Ellis. If you put the quote I gave above into Googel with inverted commas around it, you should find it.

Mole - they DO try out new drugs on animals first, before they even get on to trying it on humans. But no other species has exactly the same physiology as humans, so occasionally thery get a nasty surprise, as with the case you mention. There is a useful overview of the different phases of testing on humans here:-

cancerhelp.org.uk/help/default.asp?page=73

(I’m assuming a link to Cancer Resarch UK is OK under the BCC policy).

I definitely agree with you that anyone asking you to be in a trial should be “completely upfront with us that the outcome may not be as good or better than the standard treatment.” On the other hand, if none of us ever agreed to be in trials, there would be no more new treatments, ever, full stop.

I’ve never ben in a trial because no-one has ever asked me to be. However, if asked now, I would probably consent, possibly even to a Phase 1 trial, since I have pretty much run out of treatment options and have progressing disease. It would be quite nice to be doing something a little bit useful in my remaining months.

Hi mjmaam,

Probably the doctor didn’t talk about it because usually they have to sign an agreement not to talk about the results of a trial before the release date for the trial. Otherwise there could be problems with things such as insider training of stocks based on the leaked results of trials.

I suppose that they went with eight cycles of treatment because they didn’t want NICE to come back to them and say that the only reason taxotere had succeeded was that patients had had eight cycles. As far as I can tell, nobody has looked at whether eight cycles of FEC is better or worse than six cycles (there is no published article on this judging from the Medline abstracts database).

There are real and acknowledged problems with clinical trials. Although Mole’s suggestion that patients not be recruited when they are vulnerable would be nice, it is not generally practical. Patients need to get themselves into treatment before they can get their heads fully around having cancer this will affect the decisions they make. Terminal patients going for phase I trials may likewise be overly optimistic about trials they are asked to participate in. I believe there was a study of a phase I vaccine trial in metastatic patients in which their immune response was being measured to see if the vaccine might benefit early breast cancer patients and even though the doctors had specifically said that it was unlikely to help metastatic patients, a researcher found that the participants still were wildly overoptimistic.

There are a few things protecting patients receiving the treatment. Most phase I trials for cancer and AIDS drugs involve people who have exhausted all other options and so have less to lose if a trial goes wrong and more to gain if it goes right. Usually only one person gets the treatment at a time and the dose is gradually escalated. In my humble opinion, TeGenero or Parexel conducted the trial in an unusual and wrong way. If their drug was supposed to be used to treat diseases as serious as leukemia, why didn’t they try it out out a single leukemia patient with no other options? True, maybe that patient might not have survived the trial, but they have potentially wrecked the health of several young men. On phase II trials usually only very high-risk or metastatic patients are recruited. The protection for phase III patients is that only things that seemed to work at phase II go on to phase III. Also, only the best things go forward since phase III trials are really expensive to conduct so companies, charities and governments who experts know a great deal about cancer have to be pretty certain it will work.

Protections for control group patients seem more problematic. Hospitals have ethics boards which would need to approve studies and I can imagine that Cancer Research UK, one of the TACT sponsors, is pretty careful, although the medical profession is not always good at policing itself. NICE, the body recommending treatments, will also not recognise the results of any trial in which the control group received a treatment that might be considered substandard. Indeed, one reasons that the results of so many US breast cancer trials don’t make it over here is that the AC->taxol combo that has been so common in the US may not be as good as FEC, so NICE doesn’t accept trials where the control group got that standard US treatment. So even US trials that were on the up and up might not meet NICE standards as far as control groups go.

Having said that, I am aware of cases in the US where the treatment has changed very quickly and doctors have continued to recruit patients into trials where the control group treatment is no longer the best treatment. I am thinking about how it became possible there for a her2 positive early breast cancer patient to get herceptin almost as soon as the trial result was announced and yet some docs still tried to recruit her2 positive women into trials where the control group did not get this. However, I haven’t seen it happen here, perhaps because it takes longer to introduce new treatments out of the trials.