Bad Experience With Clinical Trial Avelumab and PF-04518600 (Long)

As some of you know I'm stage IV endometrial adenocarcinoma cancer. I have been through a hysterectomy, two different types of chemo treatment and now two different clinical trials. Only the first chemo of six cycles of Taxol and Carboplatin were successful in reducing the tumors. I then had a hysterectomy and was put under surveillance. Within three months the cancer recurred. A clinical trial and more chemo followed without success in reducing the tumors. I then entered another clinical trial, the Phase I/II clinical study on Avelumab and PF-04518600I at MD Anderson.

At the end of June, I officially left the clinical trial. But even before that, I knew the drugs were not working for me. I became very ill after my second infusion with Avelumab. I could hardly leave my bed even after four days. I thought that after a few days that I would recover, but I didn't. I began to think that I would have to enter hospice sooner than I anticipated. I was dizzy and developed tachycardia on top of the iron deficient anemia I had been fighting for awhile. I had lots of fatigue. I had many things I wanted to complete before dying.

So I have been busy taking care of myself. I live alone and have no family nearby. Thank goodness, a nephew from out of state volunteered to help me out for a week, cleaning, getting rid of stuff and advising me on paperwork. Otherwise, I have been on my own. I knew I had to find local assistance. This week I arranged to have some of my meals to be delivered and for an personal aide to help me part time. I also arranged some shopping help and transportation assistance, and I just finalizing paperwork for final body deposition and cremation paperwork. That's why I haven't updated my status on the CSN board. Too much to do and not enough energy. I feel more caught up now.

During the Phase I/II clinical study on Avelumab and PF-04518600I, I bled a lot from the PF-04518600I the first drug, that I was infused with. This is one of its side effects. So my anemia got worse. Toward the end of April, I almost left the clinical study when I realized that my tumors were growing larger. I have exophytic (external) vagina tumors so it's easy for me to tell. When I told one of the doctors in the clinical trial that the tumors were growing, he told me not to be concerned because the second drug, Avelumab was supposed to shrink them. It did not. They continued to grow. This is another study that I wish that I had left earlier than I did When will I learn? During the first injection of Avelumab, I had uncontrollable tremors and chills. This is supposed to be a common side effect of the injection of Avelumab. The nurses threw about four or five blankets on me. The vaginal tumors grew larger and I developed vaginosis. I was in a lot of pain, had a lot of discharge and the vaginosis made me stink. (TMI, yes). I asked for better pain medication because I used up all my Tramadol, that I had been prescribed a year before and had not needed to use until this. The nurse in the clinical study told me that I should go to my local clinic to be treated for my infection. I thought that this was strange because I have been going every two weeks to MD Anderson and had not been to my local clinic in more than a year. Also, I didn't think that the local clinic would know how to treat an infection in someone who was in an immunotherapy clinical trial. Apparently, the nurse in the clinical trials was unaware of how the use of antibiotics impaired the action of immunotherapy drugs. https://www.medscape.com/viewarticle/875712 Instead of relying on antibiotics and my local clinic, I treated the vaginosis with hydrogen peroxide and it went away. The gynecological oncologist at MD Anderson who had treated me before I entered the clinical study ordered a treatment of radiation to shrink the vaginal tumors, and it did.

I am now being treated with Taxol and Avastin by my gynecological oncologist at MD Anderson. I think they're shrinking the vaginal tumors. At least they are not growing. My treatments are weekly with a two week break once a month. I am grateful that I am not in pain. The two week break seems to have allowed my red blood cells to increase again. Today, I don't feel as fatigued. I hope that everyone is doing well or at least have been able to manage their pain to their satisfaction.