Clinical Trial Ramucirumab/Taxotere - 1250975

No need for clarification. We know the obvious number one needs are to help your mom. However with medication being so extremely expensive no matter how much we want it not to overshadow best care it sometimes does. However I don't think you are there at least not yet. And you may be surprised when the time comes what assistance you may receive from drug makers. Unfortunately it seems to be part of a game that shouldn't exist.

The first thing I find questionable is the suggestion that your mom receive cisplatin again. It is a platinum drug that has only shown benefit in one line of treatment. In most cases that is the first line treatment that your mom has already received. Second line standards include tarceva, alimta (in non squamous), and taxotere and then gemcitabine, taxol, and navelbine have all shown efficacy.

Your question about the trial is a good one and I'll ask a doctor to reply on the question about radiation. Though trials are usually set up to take into account those risks by excluding those that are high risk.

Also a trial is an excellent choice because your mom is at a juncture where there are lots of trial options. Most if not all doctors here would agree that this is a very good consideration.

You should here back within the day. I wish I could convince you not to worry about the money but my experience is that it is a very difficult thing not to consider. The best input on that and so many other issues with cancer is take it one day at a time...and of course having good info for decision making is a must. (says the choir)

I'm so glad you have your mom close.

All the best,
Janine
forum moderator

Hi Meli, thanks for sharing your mother's story although I am very sorry for the reason behind it.

After cancer progresses shortly after completing chemotherapy and radiation for stage IIIB lung cancer, proceeding to second line chemotherapy is a very reasonable thing to consider. The choices include both pemetrexed (Alimta) and docetaxel (Taxotere), as well as the targeted drug Tarceva. I understand that Alimta is very expensive so of course that needs to be considered, but it is well tolerated by most patients and can be effective in this setting. Taxotere is also effective in prolonging survival in patients in your mother's situation, and so would be a reasonable choice. Finally, a clinical trial is always worth considering when there is no perfect standard choice.

Ramucirumab is an antibody against the vascular endothelial growth factor receptor 2 (VEGFR2), while Avastin is an antibody directed against VEGF (which is what sticks to VEGFR2). It would be expected that they may act similarly, but in fact we do not know to what extent the side effects of Ramucirumab will resemble Avastin. There are concerns about using Avastin in patients who have received chest radiation, especially recently afterward, because of some small trials that showed fistulas (connections) between the windpipe and esophagus in patients being given radiation and Avastin at the same time and for a while afterward. In someone 6 months out from radiation, it is not clear if it is safe or not, so many oncologists would steer clear. For a new drug like Ramucirumab, we have no idea if it would be safe to give 6 months after radiation. In the controlled setting of a clinical trial, where side effects are being closely tracked, it might be something to consider since the risks are really unknown, but you would definitely want to be aware of this possible risk.

You are absolutely correct that the patients who developed fistulas tended to be those who had very severe and prolonged esophagitis, although keep in mind this is such a small number of patients that we cannot say that there would not also be risk in patients who had little symptomatic esophagitis. It makes sense that long after radiation, and with no esophagitis, that this risk should be lower but this is just an educated guess.

Ramucirumab does appear to be reasonably safe and there is experience with it, so I agree it is a very reasonable drug to test in clinical trials in lung cancer. As long as the patient and her doctor have a discussion about the potential risks and she understands those risks, and she otherwise meets criteria to participate, there is nothing wrong with proceeding. Everything in life is a risk in one way or another!

I really agree with Dr. Pennell (and your conclusions); the issue, though, is that many cases of TE fistulas are life-threatening or fatal, so you can understand why we'd be reluctant to presume we can be completely reassured. Even if it's unlikely we're incorrect in our presumptions, the consequences are potentially serious.

-Dr. West

I'm sorry to hear about your mother's bad reaction to Taxotere.
I don't know where you are in Austria but there are some other clinical trials that might possibly be suitable for your mother. Then you'd get the drugs for free, and she would be carefully monitored. If you go to www.clinicaltrials.gov, you'll see that it's possible to search for example for "Austria and Alimta", or "Austria and NSCLC". Do you know whether she was tested for the ALK when she was tested for EGFR? There is a trial in Salzburg and in Wels comparing Alimta and Crizotinib for patients who are known to have the ALK rearrangement:
http://www.clinicaltrials.gov/ct2/show/study/NCT01154140
Don't despair yet!
(PS - We don't seem to have a forum signature describing your mother's dx and treatments so far - could you do one to make life easier for the doctors and for everyone else who is responding?)

I wonder if the trialist can or are willing to use a comparable drug to taxotere for the studies. I just did a search and it seems that most are using taxotere are the comparator.

And here is a search result of studies excluding taxotere for nsclc in Austria. There are options. http://clinicaltrials.gov/ct2/results?term=-taxotere&recr=Open&cond=nsc…

Also I wonder if the makers of Alimta may give assistance to your mom since she doesn't have insurance. It's worth asking.

Janine

I don't think the trial investigator will have the flexibility to change the chemotherapy agent -- this is usually hard wired for the protocol. After someone has an acute hypersensitivity reaction (not a rare event), we can sometimes give Taxotere (docetaxel) with additional steroid premedication, like 50-100 mg of hydrocortisone, and a slower rate of infusion. Perhaps that might be an option to consider.

-Dr. West