Phase 1 Clinical Trials — Opening Doors to Cancer Cures

In 2019, Linda Duncan was diagnosed with Stage 3 colorectal cancer. At Stage 3, the rectal cancer has spread to nearby lymph nodes and is usually treated with chemotherapy, radiation therapy and surgery. Chemoradiation may shrink the cancer and make it easier to remove larger tumors and also reduces the chance of the cancer coming back to the pelvis. However, chemotherapy is not well tolerated by all patients.

Linda was one of those patients who could not endure the effects of chemotherapy. She recalls that from the very first treatment in Tulsa in January 2020, she was unable to tolerate it. When COVID-19 hit, she only went for one more treatment after that and decided that she couldn’t continue. To make matters worse, a scan revealed that the cancer had progressed to Stage 4, but chemotherapy was not an option for her. Linda said, “I was determined not to do anything unless there was something else to do.” Her doctor sent her to OU Health Stephenson Cancer Center in Oklahoma City to meet with Susannah Ulahannan, M.D., a hematologist-oncologist who specializes in the treatment of gastrointestinal cancers and phase 1 clinical trials.

Phase 1 Trials

Clinical trials are important for discovering new treatments for diseases. This includes new medicines and new diagnostics and improving screening technologies. Treatments that are discovered through clinical trials advance the field by helping diagnose patients earlier and helping them live longer. Phase 1 trials are the first stage of a clinical trial and the objective is to test the safety and side-effects of a new drug, while determining the best dose and timing of a new treatment. Linda was started with an infusion and a target drug.

Unfortunately, Linda experienced adverse side-effects to the drug which grew steadily worse. Her husband drove her from Tulsa to see Dr. Ulahannan and a CT scan was performed. The results amazed both Dr. Ulahannan and Linda. The tumors were shrinking and have been ever since. By Fall 2022, Linda’s tumors had reduced by 70% and she couldn’t be more grateful, “I’m so thankful we came here and met good people, but you know what, I’ve got to give God the credit. Everyone here (at Stephenson Cancer Center) cares about you. There’s nothing like having people really care about you. There’s kind of a peace here in this building that I feel when we come in. It’s just awesome.”

Commitment is Key

Linda is one of the oldest patients to take part in a clinical trial at Stephenson Cancer Center. Just as Linda could not tolerate chemotherapy, some other patients may not respond to it. “Having different options is very important and so is diversity in clinical trials. We need a range of ages and different types of patients. We need to know how they’ll respond and react,” explains Dr. Ulahannan. “The data we get from the clinical trials is what goes out and later becomes an approval for everyone. That patient population we look at should be a reflection of the community.” Linda’s participation in the Phase 1 is instrumental in learning more about how patients of different ages and backgrounds respond to new treatments.

Phase 1 trials require a great deal of commitment from patients as there are a lot of visits and surveillance in the early stages of the trial. Side-effects and safety are carefully monitored and that includes blood tests, biopsies, and scans, but the team at Stephenson Cancer Center are there with the patients every step of the way.

Laura Deaver is an oncology research nurse for the Stephenson Cancer Center Phase 1 program who has been working with Linda over the last two years. She said, “We work very closely with our patients — they feel like family we talk to them so much. Step by step, anything they need, we talk to them. Linda cares for us as much as we care for her, and she reflects that in how she treats the staff every day.”

The Phase 1 program is offering options to patients they would not otherwise have had. Laura said, “I believe in clinical trials — they’re amazing to be a part of and seeing the process of a drug starting out as new and watching it progress. Seeing these patients who come in who have zero options and we give them hope and then we actually see responses. We see them get extra years with their family and then watch these drugs become FDA approved. It’s a special process to be a part of and I feel like we are really making a difference.”