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Medical Forum / Diseases and Disorders / Prostate Cancer / May 2008Trial treatments
A friend of mine is just starting a trial consisting of taxotere, avastin and hormone therapy..all concurrently. First of all, has anyone heard of this particular combination? Secondly, could we as patients just request that combination or others like it if we feel we want to try it? What makes a trial, a trial? My friend had his RP last fall but his psa begain to rise almost immediately afterwards. Salvage radiation for 8 weeks did nothing, in fact his psa rose to almost 10 by the end of the 8 weeks. It's almost 20 now.... :( > A friend of mine is just starting a trial consisting of taxotere, > avastin and hormone therapy..all concurrently. "Hormone therapy"? Exactly what? > First of all, has anyone heard of this particular combination? What's involved here is science, so what EXACTLY is involved? "Hormone therapy" simply won't do,. > Secondly, could we as patients just request that combination or others > like it if we feel we want to try it? If one's clinical record complies with the standards of the study requirements, fine. Otherwise, you're out. > What makes a trial, a trial? Scientific investigation, I reckon. Regards, Steve J >A friend of mine is just starting a trial consisting of taxotere, >avastin and hormone therapy..all concurrently. >First of all, has anyone heard of this particular combination? >Secondly, could we as patients just request that combination or others >like it if we feel we want to try it? >What makes a trial, a trial? All pertinent questions and I hope you get a better answer than Steve J proffered - he wisely counsels us to learn to fish rather than accept herrings but forgets that a.s.c.p. is a reasonably well-stocked pond. A trial is an experiment in cause and effect of treatment strategies in various combinations conducted under more or less rigorous conditions. I haven't always read the detail but I know Alan Meyer has posted up some helpful posts on trials and a google group search found this:- http://tinyurl.com/4b789h I've no knowledge of the drugs you mention so can't help. I hope others will chime in. >My friend had his RP last fall but his psa begain to rise almost >immediately afterwards. Salvage radiation for 8 weeks did nothing, in >fact his psa rose to almost 10 by the end of the 8 weeks. >It's almost 20 now.... :( I'm interested in this topic too and have tried unsuccessfully to open up the subject in another thread. I'll watch this space instead.....:-) >A friend of mine is just starting a trial consisting of taxotere, > avastin and hormone therapy..all concurrently. > First of all, has anyone heard of this particular combination? There are a few here that are on three concurrent treatments and I suspect there are many trials that are studying triple combinations of ADT, RT, and Chemo. It makes sense when you think about it. Starve all the PCa cells, debulk the ones where you know they are, and then while the rest are week, hit them with chemo. > Secondly, could we as patients just request that combination or others > like it if we feel we want to try it? I suppose you could. Like I said, some here are on three therapies. Might have a problem in the US with insurance. > What makes a trial, a trial? The FDA allows testing of treatments on humans under specific circumstances and using "scientific" methods. There are, I think, three levels; the first of which is truly for humans as guinea pigs. A sizeable percentage doesn't even get the new treatment, but a placebo. And the treatment has only shown possible beneficial results in animal testing. To get into a trial either you or your doctor researches their availability in your area and if you pass the specs for the type of patient they want, you're in. > My friend had his RP last fall but his psa begain to rise almost > immediately afterwards. Salvage radiation for 8 weeks did nothing, in > fact his psa rose to almost 10 by the end of the 8 weeks. > It's almost 20 now.... :( Your friend almost certainly has systemic cancer and based on the PSAD I would not be surprised to find that he had a tumor other than inside his prostate. ADT will knock it back considerably and the chemo might take the rest out. I doubt the latter, but only time will tell.  SignaturePSA 16 10/17/2000 @ 46 Biopsy 11/01/2000 G7 (3+4), T2c RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years EBRT 05-07/2002 @ 47 PSA .34 .22 .15 .21 .32 PSAD .056 years Lupron 07/03 (1 mo) 8/03 and every 4 months there after PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years Casodex added daily 07/06 PSA <0.04, <0.05, <0.04, <0.04, <0.1 2/12/08 Non Illegitimi Carborundum > >A friend of mine is just starting a trial consisting of taxotere, > > avastin and hormone therapy..all concurrently. [quoted text clipped - 46 lines] > PSA <0.04, <0.05, <0.04, <0.04, <0.1 �2/12/08 > Non Illegitimi Carborundum Steve J: He didn't tell me what hormone therapy, but I'll find out...he starts today. Steve K: I agree his stats are not very good but he had to have clear bone scans and ct scans and a host of other tests before getting accepted in this trial, so no tumor has shown up. He was given the option of just hormone therapy, but opted for the more aggressive treatment, if he can tolerate it. BTW, I'm on my second month of (just) Lupron and pleased to say I have had no side effects (...yet). I opt for monthly shots rather than three month or longer..somehow I don't trust having 90 days worth of hormones injected all at once. On May 28, skeptic replied to me: (snip) >>> Secondly, could we as patients just request that combination or others >>> like it if we feel we want to try it? >> I suppose you could. �Like I said, some here are on three therapies. �Might >> have a problem in the US with insurance. It is my understanding that all costs of a clinical trial are absorbed by entity conducting it. (snip) > Steve J: He didn't tell me what hormone therapy, but I'll find > out...he starts today. I hope that he has some paperwork that specifically identifies the trial by type of intervention (the med being investigated, frex) and/or Study ID number. With that information, one could look up the trial details via http://www.clinicaltrials.gov/ct2/ (snip) > BTW, I'm on my second month of (just) Lupron and pleased to say I have > had no side effects (...yet). I opt for monthly shots rather than > three month or longer..somehow I don't trust having 90 days worth of > hormones injected all at once. Good thinking. And BTW, it's supposed to be 12 weeks, 84 days, not 90. FWIW, I see it as a risk that the med might lose its efficacy over time and the last part of the time the patient will be receiving a less than adequate dosage. And also, it seems to me that the longer intervals are advocated not for medical reasons but for convenience. I recall a uro during an online discussion on Medline saying that he preferred the long interval "so I won't have to listen to patients' complaints" more often. SEs are well-covered on the PCRI website at http://prostate-cancer.org/education/sidefx/Strum_ADS.html and at http://prostate-cancer.org/education/andind/Guess_TestosteroneSideEffects.html Lastly, I apologize for my earlier crankiness. Regards, Steve J > ... > It is my understanding that all costs of a clinical trial are absorbed by > entity conducting it. That was the case for the National Cancer Institute sponsored trial that I entered. They paid for everything - radiation, drugs, hospital stay, follow-up care, even parking. I didn't have to pay a penny or present any bills to my insurance provider. I don't know if all trials are like that, but I'm sure that many are. Alan I had RRP 5 years ago. I'm on my 2nd trial. MOST trials are for AIPC and looking at extending life, versus a cure. There a a few that I believe are looking at a cure. If you have insurance the researchers may bill them - if the insurance company doesn't pay - you have no cost. Sort of a situation where if they can get money they will, but don't worry about it if they can't. Check www.nci.gov select "clinical trials" There are 4 Phases to trials. a.. Phase I trials are the first step in testing a new approach in people. In these studies, researchers evaluate what dose is safe, how a new agent should be given (by mouth, injected into a vein, or injected into the muscle), and how often. Researchers watch closely for any harmful side effects. Phase I trials usually enroll a small number of patients and take place at only a few locations. The dose of the new therapy or technique is increased a little at a time. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing. b.. Phase II trials study the safety and effectiveness of an agent or intervention, and evaluate how it affects the human body. Phase II studies usually focus on a particular type of cancer, and include fewer than 100 patients. c.. Phase III trials compare a new agent or intervention (or new use of a standard one) with the current standard therapy. Participants are randomly assigned to the standard group or the new group, usually by computer. This method, called randomization, helps to avoid bias and ensures that human choices or other factors do not affect the study's results. In most cases, studies move into phase III testing only after they have shown promise in phases I and II. Phase III trials often include large numbers of people across the country. d.. Phase IV trials are conducted to further evaluate the long-term safety and effectiveness of a treatment. They usually take place after the treatment has been approved for standard use. Several hundred to several thousand people may take part in a phase IV study. These studies are less common than phase I, II, or III trials. >A friend of mine is just starting a trial consisting of >taxotere, avastin and hormone therapy..all concurrently. First >of all, has anyone heard of this particular combination? >Secondly, could we as patients just request that combination or >others like it if we feel we want to try it? As I understand it, in the United States, if a treatment is approved by the Food and Drug Administration it can be prescribed by a doctor without the patient having to be part of a trial. So for example, if someone is testing a combination of three already approved treatments, then I think any doctor can legally prescribe that combination even outside of a trial. Whether a doctor will do so depends on him as well as you. Most reputable doctors will not (or at least should not) prescribe treatments a) that they have no experience with or b) that they don't have good reason to believe will work. If a doctor has no experience with a treatment, he won't have experience with dosages and adjuvant treatments, or recognizing and treating side effects. He won't be the best man to receive that treatment from. That's why Steve J. is always recommending that people see medical oncologists, not surgeons/urologists, for medical treatment of cancer. If any treatment is not yet approved, a doctor cannot prescribe it. It is only available in approved, controlled trials. That's an important protection against quacks and charlatans who come up with unapproved treatments that don't work. In a properly conducted trial, the patients are monitored throughout the trial. If early results show that the treatment is not working, or that side effects are too great, the trial will be halted and all treatment stopped. > What makes a trial, a trial? A clinical trial is a controlled experiment. In a properly conducted trial, only those people with the specific condition and health pre-requisites being tested are admitted, the treatment is controlled, and rigorous testing is done before and after treatment to get the fullest possible information about the treatment's effects and side effects. At the end, the people conducting the trial are usually obligated to provide some follow-up care and to publish a report of the results. The National Cancer Institutes portal page for clinical trials is: http://www.cancer.gov/clinicaltrials/ From there, you can get lots of information about what clinical trials are, whether they might be right for you, and how to participate. There are stringent medical qualifications for entry into any trial but, if you meet the qualifications, they're usually easy to get into and, if my personal experience is any guide, the standard of care can be very high. You can search for trials using the NCI search form, or the form at clinicaltrials.gov. The same cancer trials appear in both websites but the search engines are different. Any trial you find will have a phone number. If you call the number, you'll generally wind up speaking to a knowledgeable nurse who will be able to answer any questions and, if you appear to qualify and they are still recruiting patients, make an appointment for you to come in, get an examination, and talk to a doctor about participating. Finally, participating in a trial can be good both for you and for all other patients. It is in clinical trials that we find out how well new treatments work. Without them there would be no advances in medicine. I think that if I knew that I were going to die of cancer I'd be very interested in participating in a trial not only as a chance to extend my life, but also to possibly do some good for other patients. > My friend had his RP last fall but his psa begain to rise > almost immediately afterwards. Salvage radiation for 8 weeks > did nothing, in fact his psa rose to almost 10 by the end of > the 8 weeks. It's almost 20 now.... :( Very sad. I hope the trial helps him. Alan |
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