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Clinical Trials 101

Hatshepsut's picture
Hatshepsut
Posts: 340
Joined: Nov 2006

In my effort to build my husband's "Plan B" for treatment should his current regimen (which we are told is his last chance with currently-approved colon cancer drugs) fall short, I need to educate myself about clinical trials.

How does a clinical trial work?

I have a gazillion questions:

1. How do you research what clinical trials are available? I read on this board somewhere today about an oncologist who simply told his patient to find a clinical trial. What?

2. When I contacted a noted researcher in Southern California recently, he commented that there are a lot of disqualifying criteria applied to applicants for clinical trials. Specifically, he noted that my husband, because he has a fistula, would be disqualified from a number of trials. Once I know how to research clinical trials, how do I determine which trials would be open to my husband? Or, does one connect with an oncologist specializing in clinical trials to sort things out?

3. Given my husband's stage IV status, would we want to be involved in early trials? (Maybe I don't understand the terminology, but stage I and II trials look like early trials to me.)

4. Does insurance cover the cost of clinical trials.

5. What about trials that put some participants on placebos? That sounds pretty dangerous to my husband, given the aggressive nature of his cancer.

I confess that I'm so new to this subject that I don't even know the proper questions to ask. For those of you who are experienced in this area, are there other considerations I/we should be concerned about resolving.

Thank you.

Hatshepsut

P.S. I don't know how long it is supposed to take to determine if a chemotherapy plan is working. Any ideas? In my husband's case, he had a definite 2-5 (on the hospital scale) pain in the area of the mass in his abdominal wall that lasted for weeks. He started Xeloda a couple of weeks ago and had his first Vectibix/Oxyliaplatin infusion at the end of March. His pain is gone. I know I want good news, but I'm hoping that that is a sign that Plan A is working.

AnneCan
Posts: 3692
Joined: Oct 2009

Hi Hatshepsut,

I don't know much about clinical trials, sorry, someone else will help you there. I am really happy your husband's pain is gone, I think that is a good sign. Soon after I began the chemo treatment I am on, I really felt it was working. My body felt different. I had a CT scan after 4 treatments + it confirmed that it was working. Best wishes to both of you.

mom_2_3
Posts: 965
Joined: Nov 2008

Hatshepsut,

I am not overly verseed in clinical trials although I am currently a participant in one for my oncologist (efficacy of adjvuvant HAI treatment after liver resection).

I know you are a great researcher and the information below is rudimentary but thought I would respond in any case.

1. Go to http://clinicaltrials.gov/ and select "advanced search." You can enter appropriate criteria. I just searched for "colon" and open and had over 900 matches. You will need to wade through these.

2. For each study there are exclusion criteria. I checked out one (http://clinicaltrials.gov/ct2/show/NCT00826800?term=colon&recr=Open&rank=15) and see that fistula is in fact an exclusion criteria. There may be an ability to search on "-fistula" in order to exclude those studies but I haven't looked into the search engine operators too much. My husband is telling me to go to sleep so I havel limited time right now. The bigger issue may in fact be age as many of the studies have age ranges that fall outside your husband's age.

3. As you mentioned, Stage I and II designed to determine safety issues with a particular therapy and Stage III is for determining efficacy. My personal opinion is that I would participate in II or III if necessary.

4. Insurance reimbursement depends on your carrier, plan and study. None of the costs of the study I am in have been "picked up" by the study itself but by our insurance. You will need to look into this further but my impression is that the more the therapy is untried the less likely it is insurance will cover it.

5. Some studies have a placebo but a lot of studies are comparisons of a standard treatment versus a new treatment or variation of the standard so that the participant has at minimum the standard care. I actually signed up to participate in another trial by my oncologist where she was looking at standard treatment vs standard treatment plus Avastin. It was a dice roll as to which side one would be in. I actually was placed into the non-Avastin side of the study but I eventually had to be dropped from it as I had an allergic reaction to Oxaliplatin and that was the main element chemo of the study.

Best wishes to you and Dixon. He has quite the soulmate and caregiver in you. He is a lucky man.

Amy

crazylady
Posts: 544
Joined: Jun 2004

HI Hatshepsut,
I don't know much about clinical trials, but I am currently on one. In my case my oncologist referred me to an oncologist that does a lot of clinical trials and he did the recearch and found the trial for me.
The trial that I am on covers all the costs except those that would normally be covered by my insurance so if I was due to have a scan normally then it would be billed to my insurance. If it was an extra scan required for the study then the study would pay. There are some out of pocket expenses such as the cost of parking and gas etc. I was able to get the study to pay for my parking when I am at the oncologists office, but if I have to go for scans the parking is not covered.

I will be on the study for two months and then have scans. If the scans show improvement or that the cancer is stable I will stay on the study. If the cancer shows growth then I will come off the study and the oncologist will look for something else.

The study seems to be rather involved and very time consuming. I have no idea if this is typical of all studies. In my case I have also experienced a lot of undesirable side effects which have caused me to come off the drug. I may be able to continue the study once the side effects subside

Personally I would not do a trial if there was a possibility that I could receive a placebo. There are many trials where a placebo is not used.

I hope this helps you in some way. I don't post often, but I do read daily. I find your posts to be inspirational. Good luck to you and your husband.
Jamie

biglaur's picture
biglaur
Posts: 72
Joined: Apr 2010

for my entire chemo experience. I had my treatment at UCSD, Moore's Cancer Center. A teaching hospital is your best bet for accessing a clinical trial. or so I've been told. It was a blind draw...whether I would receive Folfox/Oxi combo, or that combo with Avastin, or that combo with Avastin AND the clinical trial. I hit the jackpot (so to speak) and got it ALL. I was Stage IV, the drug is manufactured by Pfizer and I was in the second stage of the trial. I was assigned a case worker who met me EVERY time I had an infusion. They took blood work (separate from my pre infusion blood tests), gave me a pretty comprehensive questionaire each time wanting to know side effects etc etc, I was given a blood pressure machine (had to monitor by bp twice daily and chart it), and was required to have a ct scan every 6 weeks. Not sure how many other patients at UCSD were on it, but I was the only one left standing (others' tumors continued to grow or the side effects were too tough) I really did not enjoy it...but since I'd never had chemo before I didn't really know which drug was causing what side effect. I am now NED (as you guys say) but who knows what it was that got me there???? I know that they continued me on the clinical trial drug after I finished chemo and I didn't feel better...so I'm guessing the trial drug was the strongest of the batch. I finally cried uncle and stopped it...when I started Xeloda. If you'd like to e:mail me for specifics or my docs name etc feel free. I can give you more technical data (my husband paid attention to that, I didn't). Laurie rtpatrl@mac.com

PhillieG's picture
PhillieG
Posts: 4912
Joined: May 2005

Here is some information from Sloan Kettering about colorectal trials and at the bottom are links to clinical trails in general.
I hope this helps
-phil

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