Phase II Study on TAXOL in Bronchioalveolar Carcinoma
- Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar
- Assess the duration of response in patients presenting with an objective response.
- Characterize the acute side effects of paclitaxel in patients with BAC.
- Assess the role of some biological parameters in the natural history and the response
to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.
OUTLINE: This is an open label, nonrandomized, multicenter study.
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or
normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or
Disease is assessed every 6 weeks until documented progression; treatment side effects are
assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6
cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal
PROJECTED ACCRUAL: 16 or 25 patients will be accrued.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Giorgio Scagliotti, MD, PhD
Azienda Ospedale S. Luigi at University of Torino
United States: Federal Government