Phase II Trial of Lapatinib and Weekly Paclitaxel for Advanced Platinum Refractory Urothelial Cancer
Bladder cancer caused 14,680 deaths in 2010 in the US. In advanced bladder cancer, MVAC
(methotrexate, vinblastine, adriamycin and cisplatin) and GC (gemcitabine, cisplatin)
combination chemotherapy demonstrate comparable efficacy with response rates of 45%- 50%.
Despite the reasonable initial response to platinum based chemotherapy, median time to
progression on first line therapy is only 7 months and median survival approximately 15
months. There is no standard second line therapy after platinum based chemotherapy in the US
and no survival benefit has been noted with any agent. Median progression free survival
(PFS) is around 2 months in platinum refractory urothelial cancer (PRUC) and overall
survival (OS) is 6 - 8 months with single agent second line therapy. Combination
chemotherapy does not prolong overall survival. Given the dire prognosis in PRUC and the
lack of efficacy of conventional chemotherapy, preclinical investigations and clinical
research have focused on identification of novel molecular targets.
Lapatnib is approved by the FDA for the treatment of breast cancer. Paclitaxel is approved
by the FDA for the treatment of sarcoma, breast and lung cancers. Lapatinib and paclitaxel
are not approved for advanced urothelial cancer; however, the FDA allows the use of these
drugs in this study for research purposes.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients with platinum refractory advanced urothelial cancer over-expressing EGFR and/or HER2 who do not progress after 16 weeks of therapy with lapatinib and weekly paclitaxel.
16 weeks after participant study therapy
Ajjai S. Alva, M.D.
University of Michigan
United States: Institutional Review Board
|University of Michigan||Ann Arbor, Michigan 48109-0624|