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Medical Forum / Diseases and Disorders / Breast Cancer / December 2004Chemo with clinical trial study?
I had a lump removed from my left breast in early October, the results came back cancerous, so the Dr removed more tissue, and my lymp nodes, they came back negative for cancer. I seen the oncologist yesterday, he has scheduled a Muga scan, and a right breast mammagram, since they didn't do when when they took one of my left breast, and i have to let my surgeon put a Pac placement in my chest for the chemo.. then i go back to see the oncologist on the 13th, and chemo starts the 14th. I am 37yrs old with no insurance, so he printed me papers about a clinical study program he wants me to take. It randomly picks you from 2 groups. Group 1.... Chemotherapy.. Doxorubicin & Cyclophosphamide (both drugs given at the same visit every 3 weeks for 4 visits) & Study Capsules.... Celecoxib or Placebo.. (one capsule taken twice a day for 3 years. Group 2..... Chemotherapy.. 5 FU & Epirubicin & Cyclophosphamide. (all 3 drugs given at the same visit every 3 weeks for 6 visits) & Study Capsules.... Celecoxib or Placebo. (one capsule taken twice a day for 3 years).. Does anyone know anything about any of these drugs, and will it be ok to do this trial study? Thanks for all your help.. Carol > I had a lump removed from my left breast in early October, the results > came back cancerous, so the Dr removed more tissue, and my lymp nodes, [quoted text clipped - 36 lines] > Carol > The chemotherapies are 'ordinary'. Doxrubicin and Cyclophosphamide is commonly known as A/C (Adriamycin being the trade name for Doxrubicin) and the other is similar to the well established CAF regime, Epirubicin (Ellence) being similar to A. The 'gold standard' chemotherapy these days also includes a taxane, but both are good mainstream treatments. Celecoxib (Celebrex) is an anti-inflammatory COX-2 inhibitor. There might be a little question over this, as a drug of the same class - Vioxx - was recently withdrawn from long term use because of undesirable side effects, although there were indications that it was beneficial against cancer. I presume the point of the study is to assess whether Celebrex has similar benefits and whether the side effects are significant. Tim Jackson The studies are similar. As Tim indicated Celebrex is a cox 2 inhibitor, a nsaid (non-steroid anti-inflammatory drug) that IS in same class as VIOXX which was taken off the market, BUT same study also showed that Celebrex was relatively safe. I called manufacturer of Celebrex (Pfizer) who assured me that it wasn't going to be taken off the market. My fear is/was that because of Celebrex's anti-tumor effect that it eventually would be removed and remarketed as an anti-cancer drug at a highly exhorbitant cost--because more $$$ could be made off of it... I don't know if that will happen but I did find it a bit curious that after the study came out, when I went to get my refill of Celebrex, that instead of getting 2 standard bottles (unopened) that is was now in a generic, 4" container which contained all 200 capsules. The study was either done or included the health care insurer that we use. My next thought then jumped to an analogy of what a major company does that runs hospitals. It bought both hospitals in our community and then shut one of them down... So, will the manufacturer that showed VIOXX to be unsafe and that Celebrex was safe, eventually withdraw Celebrex (after it's patent is up or possibly sooner under a 'different' study) and then remarket it as an anti-cancer drug under a different name... << Celecoxib (Celebrex) is an anti-inflammatory COX-2 inhibitor. There might be a little question over this, as a drug of the same class - Vioxx - was recently withdrawn from long term use because of undesirable side effects, although there were indications that it was beneficial against cancer. I presume the point of the study is to assess whether Celebrex has similar benefits and whether the side effects are significant. >><BR><BR> I fear that Celebrex will be taken off the market too! When I take motrin or naprosyn my stomach hurts. Alex << When I take motrin or naprosyn my stomach hurts. Alex >><BR><BR> I half-jokingly presented my theory to my onc. and he concurred. If something like that occurs, then I think this might be some type of anti-trust violation. I am not certain but it seems like it might be. Hub doctors issue warning on Celebrex By Jennifer Rosinski Tuesday, December 7, 2004 Two Boston doctors are cautioning physicians to prescribe pain relievers called cox-2 inhibitors such as Celebrex only as a last resort in patients at risk for heart attacks. The news comes even as a new study suggests Celebrex is not as dangerous as Vioxx, a similar drug pulled from the shelves recently. ``It's more cautious advice,'' said Dr. Axel Finckh, a rheumatology researcher at Brigham and Women's Hospital who co-wrote an editorial on the class of drugs known as cox-2 inhibitors. ``We do not really know what triggered the increased heart attack risk in patients. We felt that we cannot exclude that there is a possibility of a cox-2 class effect.'' A study by University of Pennsylvania researchers reports that Celebrex does not have the same heart attack risk as Vioxx, a cox-2 drug pulled from shelves in September after a study revealed patients doubled their risk of heart attacks and stroke if they took the drug for more than 18 months. ``Vioxx had about a threefold greater risk of heart attacks,'' said Dr. Stephen Kimmel, associate professor of medicine and epidemiology and lead author of the study. ``What that implies is that all cox-2 inhibitors may not be the same.'' Finckh said more research needs to be done before physicians prescribe cox-2 inhibitors to patients at risk for heart disease - unless they are at risk for gastrointestinal ills. Many states have uninsured programs for women with breast cancer, have you checked your state's resources? Sorry to hear you are going through all this. My hair fell out around day 22 after my first chemo. The clinical trial sounds interesting. Do you have a number so I can look it up? Thanks Alex I can't get any financial help thru my state, i don't qualify for Medicaid because my husband makes just a little more than required. They have a program thru the health dept, but you have to be 40yrs or older, and i am 37.. plus you have to be diagnosed their and have all yout testing done their, and i didn't find out about this program until after my surgery. here is some website url's i found on the papers my oncologist gave me. http://www.cancer.gov/clinicaltrials http://www.cancer.gov/cancerinformation http://www.nsabp.pitt.edu Also, how long does it take for your hair to start growing back after chemo? Thanks! Carol That stinks! about not being able to qualify for any program. How about free care from your hospital? As far as hair goes, I had my first chemo in April finished in June, I remember in September having enough hair it looked like a had a really bad haircut. >I can't get any financial help thru my state, i don't qualify for > Medicaid because my husband makes just a little more than required. [quoted text clipped - 14 lines] > Thanks! > Carol |
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