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Fall 2008

Phase I Trials Offer Some Cancer Patients Viable Options

10/01/2008

Phase I Clinical TrialsWhen it comes to participating in clinical trials, many cancer patients and their physicians look for experimental treatments that have established a track record in early phase studies. But Phase I trials are also well worth consideration, particularly for patients with limited remaining conventional options. “Although the objective of Phase I clinical trials is to establish the safety, dosage and side effects of the drugs, that doesn’t mean that patients cannot derive benefit from them,” says Saeed Sadeghi, M.D., medical director of the UCLA/Santa Monica Hematology/Oncology Practice. “For patients whose cancer has progressed on other lines of therapy, enrolling in an appropriate Phase I trial is a very reasonable option.” This is particularly the case with the advent of novel drugs that have been developed based on a scientific understanding of tumor biology, adds Dr. Sadeghi. He notes that Phase I trials can be attractive options not only for patients who have failed standard therapies, but for others as well, including patients who have tumors for which there are no effective conventional treatments, and those who might benefit from studies looking at promising novel agents in combination with already-approved drugs. Most Phase I trials are open to all patients with advanced solid tumors, although some are limited to patients with particular cancers, such as certain types of breast tumors. At UCLA, most of the Phase I trials involve novel agents that aim at targets known to be important to the cancer process, such as the epidermal-growth-factor receptor, insulin- growth-factor receptor and proteins that are involved in cell division or in the actual replication of DNA.

“The UCLA program is supported by a large translational research laboratory, which puts us in the unique position to apply advances in molecular biology to the design and implementation of clinical trials,” says Carolyn Britten, M.D., director of the Phase I Oncology Program at UCLA. “We have been able to bring a variety of targeted anti-cancer drugs to UCLA for Phase I testing, with the potential to benefit patients across a spectrum of malignancies.”

Hopeful alternative

Physicians Update Fall 2008: Phase I Trials Offer Some Cancer Patients Viable OptionsIn breast cancer, the identification of novel molecular targets has led to a number of promising Phase I trials. “It’s true that we don’t have as much information about the efficacy of these agents as we do with drugs that have gone through Phase I and II testing, but in a sense these are also the newest, most cutting-edge drugs, and for patients who have been through several lines of therapy and have seen their disease keep coming back, Phase I trials can offer hope,” says Sara Hurvitz, M.D., UCLA breast oncologist. “These drugs would not have made it to Phase I without good preclinical data.” Lung cancer Phase I trials can provide a glimmer of hope for patients. “Although front-line therapy has improved, the great majority of patients don’t see their tumors shrink with second-line therapy,” says Edward Garon, M.D., UCLA hematologist-oncologist. “New agents are clearly needed for patients whose lung cancer is progressing despite multiple chemotherapeutics. There are newer, novel agents that do hold promise of being able to lead to responses in the tumors and prolong the patient’s life.” Within the last year, responses have been seen in UCLA’s Phase I program for patients with both small-cell and non-small-cell lung cancers. Although the clinical work portraying their side effects and proving their efficacy has not been done, the increasingly targeted nature of Phase I drugs makes them much more likely to produce benefits than in the past. “Now that our research has given us a much better understanding of what is going on in these tumors and how the drugs are acting, we can target Phase I agents to tumor types that we anticipate will be most likely to benefit from the drug,” Dr. Garon says.

Targeted agents

Targeted agents have the added advantage of being far less toxic than chemotherapy, notes Fritz Eilber, M.D., UCLA surgical oncologist. Dr. Eilber treats patients with sarcomas — rare soft-tissue tumors. “Once the disease has spread, there is not a lot that conventional treatment can do for this type of cancer,” he says. “That being said, novel targeted drugs have worked for several of these patients with dramatic results in the Phase I setting. So, even though they come to me for my surgical expertise, as a program we offer them these treatment options as well. The comprehensive care of advanced-cancer patients must include the ability to get them access to these newer agents and Phase I trials.”

  

Clinical Trials

More on UCLA cancer clinical trials, including a list of those that are currently enrolling patients,
can be found at:

www.cancer.ucla.edu





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