Conditions: Bladder Cancer
Keywords: Bladder Cancer Chemotherapy Bladder Neoplasms
Allocation: NA | Intervention model: SEQUENTIAL
Enrollment: 46
Healthy volunteers: no

Brief summary:
Phase I:

To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.

To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67.

Phase II:

To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy).

To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.

Detailed description:
In 2006, it is estimated that 61,420 cases of bladder cancer will be diagnosed in the United States and 13,060 people will die from the disease. This makes bladder cancer the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. Non-muscle invasive bladder cancer accounts for 70 to 80 percent of these cases and the natural history can vary widely with recurrence being common. In individual cases with high-risk clinical and pathological features (Ta, Tis, and T1) the use of intravesical therapy following complete transurethral resection of the tumor has become the standard of care. However up to 50 percent of patients treated with intravesical therapy for high-risk non-muscle invasive bladder cancer will recur. Response rates to second-line intravesical therapy are 20 percent or less in this population. Innovations in the efficacy of intravesical agents also have applications within a subset of patients with muscle-invasive disease who are undergoing complete transurethral resection in conjunction with local chemotherapy.

Arms:
arm 1: Phase I and Phase II: Patients will receive intravesical Abraxane by sterile urethral catheterization once weekly for six weeks.

Phase II: If a complete response after six weekly installations is achieved, patients will receive additional monthly maintenance instillations until there is a positive cystoscopic biopsy or until a maximum of six additional instillations have been administered.

Interventions: intervention 1: Abraxane
Intervention descriptions: intervention 1: Abraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug.

Intravesically administered, dose escalation, 6 weekly instillations

Protocol document: