Cancer Phase I Trials Enhance Knowledge and Expand Hope
As the first step in a rigorous and systematic review process, Phase I trials have three objectives:evaluate the safety of a new drug or therapy, determine a safe dosage range and identify side effects, according to Carbone Cancer Center Assistant Director and Phase I Administrator Dona Alberti, BSN, RN. Planning and executing these trials can be a challenge, but Phase I research expands clinical knowledge, helps advance treatment alternatives and creates a climate that attracts and retains experienced researchers.
What's more, involvement in Phase I trials allow Carbone Cancer Center physicians to offer the latest investigational therapies to more than 200 people with advanced cancer every year, Alberti says. Her staff of 14 research specialists and nurses generally have 40 trials open to patients – and six-to-eight more trials in development. Yet this busy program is only one component of the larger Carbone Cancer Center clinical research program. The Cancer Center each years offers approximately 300 treatment trials, including Phase I trials, Phase II trials assessing outcomes and side effects of therapies that met Phase I muster and Phase III trials comparing patient outcomes of new and existing therapies.
Three Decades of Study
Meeting the high standards of federal, state and institutional requirements is no small feat, for Phase I trials are equal parts demanding and fruitful. They are only open to patients with advanced-stage cancer that is not responding to standard therapy, and they test unproven agents. Those two facts trigger extensive institutional and governmental oversight and intense monitoring of every patient, Alberti says. However, it is working with the patients and the patients' families that provide the greatest reward for doing early drug development.
Committed to a High Quality Comprehensive Program
The Invaluable Contributions of Patients
As Carbone Cancer Center Associate Director for Clinical Research, Bailey has seen agents such as 5-FU and taxol become the focus of multiple Phase I trials, as they are evaluated in new cancers or tested in combination with other therapies. In recent years, Bailey has helped design and run trials aimed at preventing cancer among at-risk populations such as organ transplant recipients.
Yet Bailey cannot consider the many accomplishments of Phase I trials without being awed by the invaluable contributions patients make to these investigational studies: "The patients and the families make this research very enjoyable; they’re wonderful to work with," he says.
"We know from others' research and our own observations that most people who enroll in a cancer study do so because they hope it helps them … yet I continue to be amazed, ultimately, at how resilient and honorable people are," Bailey says.
"They want help for themselves, but they are also willing to help others they may never know."
Date Published: 03/14/2008