Phase I Drug Trial Using Gemcitabine Intravesical Gemcitabine Therapy for BCG Refractory Superficial Bladder Cancer
Superficial bladder cancer remains the most common form of bladder cancer encountered in the United States. Over 75 percent of patients with bladder cancer have the superficial form of the disease and require long-term therapy and monitoring.
One of the mainstays of therapy for patients with superficial bladder cancer who suffer multiple relapses or who have high-grade tumors with or without invasion of the bladder lining or carcinoma in situ is the use of intravesical chemotherapy or immunotherapy.
Since its introduction in the 1970s, Bacille Calmette-Guerin has consistently provided the best control of relapse — and some believe progression — in patients with high-risk bladder cancers. Other agents with slightly less efficacy but substantially fewer side effects, such as mitomycin C, have also been used with good effect in many patients.
New drugs are needed, however, because even the best therapies available today only provide a 30 percent to 50 percent chance of long-term disease control. The Bladder Cancer Research Center has a strong investigational interest in new agents to treat superficial bladder cancer. In the past two years, two novel agents (Taxol and gemcitabine) have been studied in patients with chronically relapsing low-grade superficial disease. The gemcitabine trial is still accepting patients. Additional agents will be introduced in the coming year.