My colorectal cancer clinical trial story
Phase I clinical trial takes colorectal cancer prognosis from hospice to healing
October 18, 2016
Medically Reviewed | Last reviewed by an MD Anderson Cancer Center medical professional on October 18, 2016
Tim Givens considers himself blessed.
Despite being diagnosed with chemotherapy-resistant colorectal cancer three years ago, the 71-year-old is not only alive; he¡¯s also in remission.
¡°Tim realizes he¡¯s a miracle,¡± says his wife, Janie. ¡°His prognosis went from hospice to life.¡±
It¡¯s all due to a Phase I clinical trial at MD Anderson, and a doctor¡¯s willingness to experiment with a drug that was originally used only to treat advanced melanoma.
Colorectal cancer signs
Tim¡¯s journey to MD Anderson began in May 2013, when he started feeling weak and full, even though he hadn¡¯t eaten very much.
¡°I thought I had ulcers,¡± Tim says, ¡°It was always just a small ache.¡±
But one day Tim called Janie while she was traveling for work and asked her to come home. ¡°My husband had always been very active, and he was never sick,¡± Janie says. ¡°So I knew something must really be wrong.¡±
Choosing MD Anderson care close to home
Janie took Tim to a doctor close to home in northwest Houston. That physician discovered Tim was severely anemic. A lower gastrointestinal tract test also revealed a large tumor in Tim¡¯s colon. It was removed at a nearby hospital, but Tim opted to come to MD Anderson for additional treatment.
¡°We knew he was going to have to have an oncologist,¡± Janie says. ¡°We called several, but didn¡¯t like their responses. Finally, we called MD Anderson and got in within a week at the Woodlands location. We established a really good rapport with our care team there. And we were excited that Tim could get his care so close to home.¡±
BRAF genetic mutation leads to Phase I clinical trial
At MD Anderson, Tim finally began chemotherapy. Unfortunately, it didn¡¯t work. Tim started to feel sick again about two months later, and he complained of a nagging backache. A CT scan showed that the tumor had grown back. It was the exact same size as the original.
¡°We were flabbergasted,¡± Janie says.
¡°I didn¡¯t understand what was going on,¡± Tim says. ¡°I thought, ¡®Why am I different?¡¯¡±
Additional testing revealed that Tim also had a BRAF gene mutation, which keeps chemo from working. He was encouraged to consider a Phase I clinical trial that would use an existing medicine in a new way.
¡°We met with and he said it was an experimental chemo,¡± Tim says. ¡°He also said he couldn¡¯t guarantee anything, but that it had worked in some of his other patients. So I said, ¡®OK, let¡¯s do it.¡¯¡±
¡°We were told there was really nothing else they could do, unless Tim wanted to consider this Phase I clinical trial,¡± Janie says. ¡°The trial was just beginning, but it was our only hope.¡±
Phase I clinical trial proves highly effective
Tim started taking Vemurafenib experimentally, along with a pair of more traditional chemo drugs: Cetuximab and Irinotecan. Eventually, severe weight loss forced Tim to stop taking the last drug. But he remains on Vemurafenib.
Tim has been on this trial for about two-and-a-half years now, and he has seen a complete response, which means he has no evidence of disease.
¡°The doctors were so excited,¡± Janie says. ¡°Tim is considered their star because he¡¯s responded better than anyone else. Now they¡¯re testing his blood to see what sets him apart.¡±
¡°It all boiled down to if I wanted to live,¡± Tim adds. ¡°If I hadn¡¯t taken the pills, Dr. Hong said I might not have been here in four months. I don¡¯t think I could have found this clinical trial anywhere else. So if I¡¯m on chemo for the rest of my life, then I¡¯ll do it.¡±
I don¡¯t think I could have found this clinical trial anywhere else.
Tim Givens
Survivor