Trial of Lapatinib and Weekly Paclitaxel for Advanced Urothelial Cancer
Status:
Withdrawn
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
Summary
This study will involve subjects who have advanced urothelial cancer who are platinum
refractory (platinum based chemotherapies that are not effective in treating the cancer), and
who are over-expressing EGFR and/or HER2, or do not over-express EGFR and HER2. Genetic
expression is a process that takes inherited information in genes (like DNA sequence), and
from that information makes a specific functional product (sometimes called a gene product)
such as RNA (ribonucleic acid) or protein. Normal tissue cells have a particular genetic
expression, which changes when they turn into cancer. EGFR and HER2 are involved in the
process by which normal cells are transformed into cancer cells.
The main purpose of the study is to look at the proportion of subjects, who over-express EGFR
and/or HER2, who do not progress (cancer gets worse) after 16 weeks of study treatment with
daily lapatinib and weekly paclitaxel. The study will also look at the safety and
effectiveness of this therapy in all subjects.
Another part of this study will look at blood and tissue samples. Blood samples will be
collected to see how many cells express EGFR and HER2 before study treatment and at the time
the cancer gets worse. Tumor tissue will be analyzed to look at the expression of certain
genes in advanced urothelial cancer. Some gene expression tests can reveal how cancer cells
are different from normal cells and the results might lead to more accurate diagnosis and
treatment.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center