Phase I clinical trial takes colorectal cancer prognosis from hospice to healing

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 Dr. David Hong 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.”