Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder
Recurrent Bladder Cancer
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Drug: lapatinib ditosylate
Other: immunohistochemistry staining method
Genetic: fluorescence in situ hybridization
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Arm Phase II Study of Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder as Second Line Treatment|
- Progression-free survival rate [ Time Frame: At 12 weeks ] [ Designated as safety issue: No ]Defined as the time period from the start of treatment and documented progression or death without documentation of progression. Summarized with Kaplan-Meier curves. The median will be estimated using a non-parametric method.
- Objective response rates [ Time Frame: After 6 and 12 weeks and then every 9 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 6 months for up to 2 years ] [ Designated as safety issue: No ]
- To study tolerability and safety by assessing the incidence and nature of Grade 3, 4 and serious adverse events [ Time Frame: Weeks 1, 4, 7, 10, 13, 16, 19, 22 and then every 6 months for up to 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Patients receive docetaxel IV over 1 hour on day 1 and lapatinib ditosylate PO QD on days 1-21. Courses repeat every 21 days until disease progression or unacceptable toxicity.
Other Names:Drug: lapatinib ditosylate
Other Names:Other: immunohistochemistry staining method
Other Name: immunohistochemistryGenetic: fluorescence in situ hybridization
Other Name: fluorescence in situ hybridization (FISH)Other: laboratory biomarker analysis
I. To assess the efficacy of 1250 mg of lapatinib (lapatinib ditosylate) given in combination with docetaxel in prolonging progression-free survival of subjects with metastatic, previously treated transitional cell carcinoma (TCC) relative to historical controls.
I. To assess the efficacy of 1250 mg of Lapatinib given in combination with docetaxel in the objective response rates and overall survival.
II. To study the tolerability and safety of 1250 mg of lapatinib given in combination with docetaxel by assessing the incidence and nature of Grade 3, 4 and serious adverse events (AEs).
I. To assess the expression status of epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER-2) in tumor tissue and/or circulating tumor cells (CTCs) as potential predictors of response to therapy.
II. To evaluate the number of CTC's present in 7.5mLs of peripheral blood as a predictor for disease progression and response of treatment in bladder cancer in the setting of combination therapy of lapatinib and docetaxel.
III. To evaluate the effect of lapatinib in human at molecular level by targeting the phosphorylation activity of the AKT/extracellular-regulated kinase (ERK) on pathway prior and during the treatment with lapatinib.
OUTLINE: Patients receive docetaxel intravenously (IV) over 1 hour on day 1 and lapatinib ditosylate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382706
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||David Quinn, M.D.||University of Southern California|