Topic: chemotherapy/clinical trial advice

I just joined the forum and would love to get the group's thoughts on clinical trials. I'm looking into a clinical trial for my father, and am finding that I'm a bit confused about the process. I'm posting this in the chemotherapy forum as well because it seems that chemotherapy clinical trials are often discussed in the that forum. By way of background, my father has extrahepatic cholangiocarcinoma. He had surgery (the Whipple procedure) where the doctors were hopeful they had a full resection, but followed up with radiation (with Xeloda) and then Gemzar just in case there was microscopic residual of the disease.

Just last week, (6 months after surgery and in the middle of Gemzar) we got confirmation that the cancer is definitely back, most likely in a few local lymph nodes and what sounds like sort of scattered around the area of the surgery, but not a well-defined tumor in one particular location. We were told that surgery and radiation are no longer options, only chemotherapy.

My dad's oncologist has agreed to delay the next phase of treatment (combination Gemzar and Cisplatin) for two weeks in order to allow us to search for a clinical trial. I would really appreciate any advice that you might have along the following lines:

1) what recommendations do you have for finding a clinical trial? I have found a number of clinical trials for recurrent and/or unresectable extrahepatic cholangioc on cancer.gov and clinicaltrials.gov. However, since I'm not a doctor, I don't really know how to go about figuring out which ones would be the most promising, or which ones would be the best fit given the specifics of my dad's cancer. We also are under time pressure since we only have 2 weeks until the Gemzar/Cisplain starts so I want to try to focus on trials that look the most promising and that my father is most likely to qualify.

2) I know every trial is different but the one we were hopeful about now looks like my father will not be eligible because of his prior radiation and chemotherapy treatment. For others that may have been looking for clinical trials for a longer period of time, I'm wondering if you have found this to be a common problem, or if some trials are more flexible on prior treatment. Also, does anyone have an opinion as to whether it would be more difficult to get my dad on a trial after he has had the 9 weeks of Gemzar/Cisplatin?

3) Even if we are not able to get him into a clinical trial right now, I'm wondering if he can get treated with the same drugs, just outside of a trial. I've noticed that many people on this forum are being treated with the same medications that I see listed in clinical trials. Is it possible to be treated with these medications outside of a clinical trial? I guess that means it isn't "approved" for this type of cancer, but if it looks promising enough for a doctor to recommend you go to a clinical trial, why not just treat with the same drugs if you can't get into the trial? Has anyone had success at some of the major cancer centers in getting treatment with clinical trial type drugs but outside of a clinical trial?

4) I really want to take my father to one of the large cancer centers such as MD Anderson in Houston. However, I'm having some trouble making headway over there. If anyone has any advice on who to contact or how to find someone to review my dad's records, please let me know. I called the main number and was directed to the GI patient access services. The woman I spoke with basically said that they could not see my father because he had already received a round of chemotherapy. Instead, she said I would need to talk to their center for targeted therapy, which does clinical trials. When I contact that office, I'm always transferred to a voicemail box. I have left three messages over the past week, but I have yet to get a return call. Any advice on how to get through?

5) We actually have an appointment at the Mayo Clinic next week, but they will not look at records in advance. I am hesitant to have my father travel to the Mayo Clinic only to have them look at his records and not offer us anything new. Does anyone have any advice/experience with going to the Mayo Clinic not necessarily for a diagnosis, but to find out about new treatment options and available clinical trials?

Thanks everyone in advance for sharing your advice and experiences. I've been reading the forums on this site ever since my father was diagnosed and I appreciate all of the information that you all have shared.

2 (edited by marions Wed, 13 Oct 2010 22:47:28)

Re: chemotherapy/clinical trial advice

Hello favoritedaugher

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: chemotherapy/clinical trial advice

Hi Marion,

Thank you so much for your quick and thoughtful response. I wanted to respond to you sooner but today was an eventful day (but mostly in a good way) in the quest for treatment options. Your feedback and support is very helpful. I was wondering if you could tell me more about the advocate that you mentioned. I'm not familiar with that type of role.

Thanks again!

Re: chemotherapy/clinical trial advice

Hi Marian,

We have worked with Dr. David Cosgrove at Johns Hopkins.  He has coordinated well with our local oncologist and has been very responsive by email.  dcosgro2@jhmi.edu
Feel free to tell him Dennis and Ellen Moore referred you.

All the best.
Ellen

5 (edited by marions Sun, 17 Oct 2010 17:15:41)

Re: chemotherapy/clinical trial advice

Favoritedaugher......Patient Advocacy is numerous however, in your case I am referring to the patient advocate involved in cancer research.  Advocates participate in the process of development of the clinical trial, develop patient-friendly forms including, educational material, and they emphasiaze the impact of the resarch on the lives of patients.
Additionally, they play an important part of the peer review process. 
Cancer researchers and patient advocates answer questions that advance patient care, improve quality of life, and enhance cancer survivorship. Cancer researchers and advocates seek to ensure that clinical studies are well-designed and ethical therefore, minimizing patient burdens.
Therefore, if you are able to locate a clinicial trial appropritate for your Dad, it might be benefitial to seek out the advocate instrumental in the approval of the clinical trial.
I hope this helped.
Best wishes,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER

Re: chemotherapy/clinical trial advice

Hello Ellen....thank you much for sharing this information.  Although, we see it freaquently, but not always for a physcian from a larger institution to direct and work with a local oncologist. 
Thanks again and best wishes,
Marion

THIS INFORMATION IS NOT INTENDED NOR IMPLIED TO BE A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE. YOU SHOULD ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH CARE PROVIDER