Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
Study participants will have been diagnosed with bladder cancer that has invaded the muscle
wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the
bladder. Unfortunately, approximately 50% of people may have their cancer return in another
location. For this reason, researchers are focusing on new chemotherapy regimens to be given
before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.
Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder
cancer cells.
ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard
paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated
castor oil). However, these additives are felt to contribute to the side effects (possibly
severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver
more drug to tumor cells. ABI-007 is approved by the United States Food and Drug
Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being
evaluated in other cancers in research studies.
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin
and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center