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Could someone explain the pros/cons of clinical trials. Im sure I don't have the proper understanding but I can't help but think that if you engage in a "trial" that it's like being a guinea pig. What are the upsides to participating in a trial.
Cancer Taxol Surgery Renal cancer Carboplatin Avastin Ovarian cancer
Clinical trials are a way of testing new drugs, new drug combinations, and new drug regimens. For example, there are some drugs that work well for other cancers, and are now being tested for Ovarian Cancer with great success. Most of the time people are not accepted into a clinical trial until they can demonstrate that a proven therapy (as in the gold standard carbo/taxol combination for ovarian cancer) has not worked for them. Some trials are targeted at specific types of ovarian cancer, or whose participants meet specific criteria. (One of my friends barely had enough tumor to qualify for the clinical trial she is in.)
In some ways you may be a guinea pig, in that they are collecting data to see how effective a treatment is, but most of the time with a Stage III clinical trial they are giving you the best option available based on your cancer, but one that has not yet been officially approved -- hence may not be compensated for by health insurance. A trial may be the only way to get it.
My doctor was telling me about a wonderful drug for those with recurrent Ovarian Cancer that is making its way through the FDA bureaucracy; so it won't be available to the general public for 3-6 months.
We're all reaping the benefits of clinical trials that have been done in the past, and those that participated were the first to benefit from these new drugs and drug combinations.
Depending on where you are in terms of recurrent disease, you may be eligible for Stage III, Stage II, or Stage I clinical trials. Stage 1 are usually smaller, broader in scope (such as for any type of solid tumor), shorter in duration, and just testing to make sure that they don't cause patients harm. Often those for whom nothing has worked are involved in Stage I trials.
Stage II are larger trials, and may hone in on specific cancers based on Stage I results. Stage III include the most number of people, and are done just prior to seeking FDA approval.
I should add that in the clinical trials process some participants will receive the new drug or combination, while others in a control group will not. This enables the investigators to determine the efficacy of a particular regimen. Sometimes they will cancel a trial before its end date if they discover that there are too many poor outcomes on either side (with the new treatment, or in the control group). They go with the preponderance of the evidence.
Hope this helps, but if this is your first recurrence, they have really good therapies available. Best of luck to you.
I decided to participate in the GOG 0218 clinical trial (it is a phase III study) after my initial surgery for stage IIIc OvCa) because I would receive standard therapy (Taxol and Carboplatin) and have an additional opportunity of possibly receiving Avastin. Though this is a double blind study -- I may be receiving placebo and not Avastin I am at least getting standard therapy. Participating in the study may or may not benefit me personally but the study results will help find the answer if Avastin is helpful given with first-line therapy and /or maintenance therapy.
Avastin is FDA approved for Colon, Breast and Non Small Cell Lung Cancers. Hopefully will soon be FDA approved for recurrent OvCa but most insurance companies are now paying for it due to the results of clinical trials
I thank our OvCA sisters who participated in the OvCa recurrence clinical trials because through those studies we now know that Avastin can help with recurrences.
Besides now having OvCa I have been a clinical trials research oncology nurse for 30+ years--I will be glad to try to answer any clinical trials questions you may have.
PS to MinnieM: You gave helpful definitions but clinical trials are referred to as phases not stages.
We are guinea pigs, but you know what, that's OK with me if it works or helps. I am in a phase I clinical study. There will be 54 participants. We will all be getting the drug, but in different doses. It has proven to work well with certain types of lymphomas.
Some positives of clinical trials? You get monitored very closely and have a trial nurse at your beck and call <g>. While I realize we are guinea pigs in some ways, I look at the trials as a real opportunity. We get the chance to try cutting edge drugs--the downside is that we may find they do not work as well as the current drug, but frankly if the current drug worked so well on us...we wouldnt be in a clinical trial.
I am in a Phase 1 trial and am a bit unusual as I have only had Carbo/Taxol. I had disease progression on 1st line chemo plus I have clear cell, both of which are poor prognostic indicators. I have the opportunity to try 3 drugs which are all FDA approved but have not been used together. Doxil, Avastin and Torisel. The Torisel is used in clear cell renal cancer which is histologically identical to clear cell ovarian. The likelihood of Doxil alone working on platinum refractory patients as a monotherapy ranges from 7 -12% ( as far as I have found). Definitely nothing to get excited about.
I am at MD Anderson so there are a lot of clinical trials available and the Oncologists tend to push them. But even in the phase 1 trials where they are setting doses for safety, something like 75% of the 90 or so phase 1 trials at MDACC deal with drugs that are already FDA approved. I do understand the concern about a drug being first in humans...not a lot of comfort knowing "but gee, it worked well in mice".
Admittedly I am a bit of a research nerd as I have a MS in Toxicology and have spent far more time than I care to admit working on research. However, EVERY advance in chemo is directly related to people before us choosing to take part in a trial.
I will admit that the people running the phase 1 trial were almost giddy to get a patient who only had failed one line of chemo! Also, the phase 1 clinic tested my tumor for sensitivity to PIK3, NRAS, EGFR and several other markers. The other reason I am on Torisel is that I am positive for PIK3 which is part of the mTOR pathway--Torisel is a mTOR inhibitor. So we have evidence ahead of time that this particular drug should work on my cancer.
I get my first CT scan next week and will be scanned every 6 weeks; meet with the phase 1 Team weekly. I sneeze too hard and they are checking up on me. It is kind of reassuring.
Just my thoughts
Teri Jakob
I can give you an example of why to do clinical trials:
I am in recurrence after 24 months of remission for stage 3a ovarian cancer. When it recurs you are automatically stage 4. When they diagnosed my recurrence in Oct 2008 they also sent cancer cells to an assay lab. They grow the cells there and add chemos to them to assess if anything works and what works best. The result stated that the only thing that would work is Gemzar and carboplatin. We started with that and after the 3rd treatment I was allergic to carbo ( not rare in platinum drugs after about 6 to 10 treatments). So they stopped that and tried Gemzar alone. Then they tried Topotecan (some stabilizing), then Gemzar again. Essentially nothing worked. At just the time when my oncologist was deciding she didn't want to give me Gemzar anymore, she realized that a clinical trial was beginning at my cancer center. It is a double blind study of taxol and morab 003 or taxol and a placebo. 66% of the participants would get the "good stuff" and 33% would get the placebo. Everyone would get the taxol. NO one knows who gets what because a computer decides. The pharmacist knows because he has to mix the stuff. But he can not tell anyone. The trial lasts 5 years I think. At first you get both drugs every week,for 12 weeks, then they switch to every three weeks with one week off for a while, then when/ if you can not tolerate the taxol, the continue the morab 003 until/if your condition worsens.
The assay lab said that pacitaxel (taxol) would not work for me. We all knew that I had no other hope but to take the risk to try this trial. I am a very healthy almost 65 year old who continues to work and live my life. I have always felt excellent and still do. The tiral drugs have been easy for me to tolerate. My CA125 #s were in the 900s and after 4 rounds of this trial they DROPPED to 133!!
If it continues to work for me, you can see why there is a definite pro to doing this trial. Another one is that I am helping the powers that control things know how this works on my kind of oc. (epithelial, undifferentiated, metastisized) What I am doing will definitely help others with this disease. I am hoping it continues to work for me and buys me enough time until they find the actual STOP drug for this incidious disease. I hope I have given you food for thought.
I think this trial saved my life for now.
Worth every minute!!!
Be well.
iListen
I hope this will get out words to promote clinical trials. Because I can give a great and current example of why to do clinical trials:
I am in recurrence after 24 months of remission for stage 3a ovarian cancer. When it recurs you are automatically stage 4. When they diagnosed my recurrence in Oct 2008 they also sent cancer cells to an assay lab. They grow the cells there and add chemos to them to assess if anything works and what works best. The result stated that the only thing that would work is Gemzar and carboplatin. We started with that and after the 3rd treatment I was allergic to carbo ( not rare in platinum drugs after about 6 to 10 treatments). So they stopped that and tried Gemzar alone. Then they tried Topotecan (some stabilizing), then Gemzar again. Essentially nothing worked. At just the time when my oncologist was deciding she didn't want to give me Gemzar anymore, she realized that a clinical trial was beginning at my cancer center. It is a double blind study of taxol and morab 003 or taxol and a placebo. 66% of the participants would get the "good stuff" and 33% would get the placebo. Everyone would get the taxol. NO one knows who gets what because a computer decides. The pharmacist knows because he has to mix the stuff. But he can not tell anyone. The trial lasts 5 years I think. At first you get both drugs every week,for 12 weeks, then they switch to every three weeks with one week off for a while, then when/ if you can not tolerate the taxol, the continue the morab 003 until/if your condition worsens.
The assay lab said that pacitaxel (taxol) would not work for me. We all knew that I had no other hope but to take the risk to try this trial. I am a very healthy almost 65 year old who continues to work and live my life. I have always felt excellent and still do. The tiral drugs have been easy for me to tolerate. My CA125 #s were in the 900s and after 4 rounds of this trial they DROPPED to 133!!
If it continues to work for me, you can see why there is a definite pro to doing this trial. Another one is that I am helping the powers that control things know how this works on my kind of oc. (epithelial, undifferentiated, metastisized) What I am doing will definitely help others with this disease. I am hoping it continues to work for me and buys me enough time until they find the actual STOP drug for this incidious disease. I hope I have given you food for thought.
I think this trial saved my life for now.
Worth every minute!!!
Be well.
iListen
kalo, I was asking this same question just a month ago. It is scary to go on a clinical trial. I went on to the american cancer society web page and there was "clinical trials" on their menu. Once there I click on the "all you need to know about clinical trials" It was about 16 pages long and after printing it I found it very informational.
Yes, we are guinea pigs. But all chemo drugs have been threw a clinical trial and their have been many guinea pigs before us.
You need to search your soul, talk with family members and your doctor, pray, pray, pray, and find the desission that is right for you.
You are on the right track with just asking this question on here, keep asking till you feel comfortable with the answers (even if they are answers that you don't like)
I was Dx. IIIA in 2005 and had the standard 6 carbo/taxol treatments followed by a year of maintenance chemo. I had my first recurrence last summer and had treatment with gemzar/carbo (6 rounds)and went back in remission. My oncologist told me about a phase 2 trail that I would qualify for with a drug identified as GDC0449. It is double blind trial, (which means I may or may not be getting the drug). I decided right away to participate for a variety of reasons-we are all really "guinea pigs" in a sense, ater all and I didn't want to ever have a recurrence and do woulda, coulda, shoulda thinking if I didn't do it, and I know I would get very close monitoring (monthly blood work and Dr. visits and bimonthly CT scans) all free and I knew I could pull out if it appeared that my numbers were going up or CT showed something and would also be able to stay on the drug after the trial ended if it seemed to be helping. I have been on it now for 7 months. Although the Dr. doesn't know who is or isn't getting the drug, we are pretty sure I am getting the drug because I have been having some side effects and nothing else has changed but this drug--all are bearable given the alternative! It's really a personal decision and I guess if for no other reason, the limited treatments we have today are the result of trials in the past, and for that I'm grateful--maybe the one I'm on will bring results for some in the future--hope this helps Nancyt
Shamrock2009,
Thanks for the pickup. I would blame it on "slip of the fingers", as opposed to slip of the tongue, but I think it's more "slip of the brain". I'm hardwired into thinking about everything in terms of stages now that I've been through chemo. :-)
Hi, like all have already said, clinical trials are testing the unknown result so, yes, those participants are guinea pigs. And, it is a personal decision. I read somewhere on one of these forums, that clinical trials are a glimse of future treatment while traditional treatments are a glimse of the past and present. With ppc a very difficult cancer to treat, looking at a glimpse of future treatment and the possibility of benefiting from something cutting edge...... clinical trials are, perhaps, an additional piece of hope. plus, as some have said,such close monitoring, can be quite comforting on our scary days.
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