Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer
Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin
and gemcitabine in the treatment of patients with advanced bladder cancer.
Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based
chemotherapy in this setting has activity but is not curative. Furthermore, patients with
this disease have comorbidities that limit the use of cisplatin based therapy. Combination
paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient
population.
Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which
contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is
a form of paclitaxel that 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 based on superior anticancer effect, and is
being evaluated in other cancers in research studies.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center