Second line treatment after FOLFOX fail

[JENNJ]

Hello,
I'm new to this but my Dad was diagnosed late last year with CC. After 10 rounds of FOLFOX (dropping the oxaliplatin after 9 due to neuropathy) his CEA has started to climb back up. His oncologist wants him to enroll into a clinical trial that involves Irinotecan, cetuximab and vemurafenib. If he chooses not to do that then she can offer him 5FU, avastin and Itinotecan. He tolerated the FOLFOX really well except for the neuropathy that set on after the 9th round. He feels great and looks awesome, this has come as a shock to us all. He was hoping to start Xeloda next week but that has been scrapped for now. Any insight on which to pick? Both regimens seem to have some hefty side effects. He is still working full time and has a great quality of life now.

[Sleen]

He may want to check out the TIL clinical trial. If he's got a tumor that can be relatively easily removed, and he could safely be off chemo for 3 months before a surgery to excise a tumor, the National Cancer Institute in Bethesda, MD may accept him into the trial.

Link to trial NCT01174121. Read the inclusion AND exclusion criteria before phoning the NCI. This is the trial that I've been accepted into. I'm waiting for NIH/NCI to call me back for infusion of my TILs, which should be in the next six weeks or so. Lilacbreastedroller, a member here, is at the time of this writing, recovering at NIH from this same protocol.

This thread talks about things to consider when evaluating a trial.
Read this thread for further info on the TIL trial as it applies to members here.

Feel free to PM me if you'd like.
Best of Luck to your Dad!

Celine

[JENNJ]

Celine-
Thank you so much for your reply. Navigating the world of cancer is overwhelming so any input is so greatly appreciated. My father unfortunately has "innumerable" liver mets so excise is not an option currently.

[Sleen]

Actually, for this trial, innumerable liver mets might not be such a bad thing. The treatment requires that at least one tumor can be surgically removed. The docs remove the tumor at the hospital at NCI, and use it to create the "biologicals" that are then used for the protocol. They're looking for tumor-infiltrating lymphocytes (TILs) in and around a live tumor, that's why the surgery has to be completed on their site--they rush the tumor directly to the lab after removing it.

They took two lung mets from me, but the tumors don't have to be lung mets. As long as surgery to remove one or more wouldn't be too detrimental to the patient, I was told they could use tumors from "anywhere". They're looking for a tumor that is at least 1-cm across.

If they find TILs around your Dad's tumor, they'll grow more of them (the TILs--not the tumor!) in the lab. They'll slice up the tumor and try to determine which TILs will attack it. If any do, they'll grow those specific ones until they have billions of them. Many steps happen after that, but eventually if all goes well, your Dad's own TILs would be infused back into his body, and the hope would be that those cells would then attack ALL of the cancer cells in his body, wherever they are.

That's a very basic idea of what the trial hopes to accomplish. It sounds like your Dad is healthy enough to give this one a try. It wouldn't be a cake-walk. The process has several steps leading up to it, some wait-time (where I'm at now), and then a 3 to 4 week hospital stay at NCI in Bethesda, MD. Travel costs, once he is officially accepted into the trial (ie after surgery) are covered for the patient by NCI. All medical expenses are covered as well. Companions/family expenses are not covered, however, there is a lodge on the property where up to four family members may stay, free of charge, during the patient's treatment (subject to availability).

Hope that clarifies things a little better.
Celine

[JENNJ]

Celine,
I cannot thank you enough for all the valuable information. I actually called Dr Rosenberg's office to speak to them regarding my father and am waiting to hear back. I will keep you posted- THANK YOU!
Katy

[skypup]

Katy, the TIL study may be a good option for your dad, and it is good you are collecting info. But be sure and check what results have been had in humans to date.

I took a quick look at vemurafenib and it is heartening that it has shown some success for melanoma. From what I saw it looks like they are getting 6-18 increased OS, and this is good in our world. You'll already know that Celecoxib is a drug of much hope for us CRCers, if you've been reading the threads. I presume your doc has checked that his BRAF mutation is the one appropriate for vemurafenib.

FOLFIRI plus Avastin is the known agent and would be typical second-line treatment.

These are three good choices. Here is what I would be thinking: Folfiri plus Avastin is known, is usually effective for a while. It is a good choice, but one that would still be on the table if I tried something else first.

The TIL study is new with few results and would entail quite a bit of inconvenience (being off work for an extended period of time, etc.) For me, I might pass because of the unknowns only because there are treatments that should work for a while at least still available. (I've done two clinical trials already, so I'm not just trial-averse.)

The vemurafenib has shown some success in the melanoma world, so I'd be getting a pretested drug. It would also include irinotecan, a drug that I have gotten a good three or four years and counting out of, and Celebrex, an exciting addition.

So, for me, I would opt for the vemurafenib mix. I offer you my thinking just as an experienced patient, but I'm not a doctor, have no in-depth knowledge and encourage you to keep getting opinions and checking all options out.

Wishing you and your dad the very best!

[JENNJ]

Skypup,
Thank you so much for your detailed reply. Like I said in previous posts, this is difficult world to navigate. After speaking to my Dad's oncologist she has decided to start him on FOLFIRI with afilbercept until we get approval for cetuximab with vemurafenib. She feels strongly that since my Dad's initial response was so good that we have a chance of some response with this combination. I have been reading about Celebrex and just emailed his oncologist to ask about it.
He is young (59) and still working full time. He is on no meds except chemo and Ambien, he's had sleep issues before this started. I feel being aggressive is doable since he's so "healthy".
Thank you again for all your input
Katy

[skypup]

Oh, I feel silly. I had Celebrex on the brain and misread. I see the trial is with cetuximab. I'm on it, and it's a pain, but seems to be effective. Ignore the Celebrex comments, sorry! Don't think I messed up on anything else.

[JENNJ]

Oh ok! Thank you for clarifying! I've done so much "research" online the last few months I get confused as well! How are your side effects of the cetuximab? If you don't mind me asking