Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 5:19 PM
Study NCT ID:
NCT01382706
Status:
TERMINATED
Last Update Posted:
2025-10-09
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Single Arm Phase II Study of Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder as Second Line Treatment
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial not progressing toward scientific goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as second-line therapy works in treating patients with stage IV bladder cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel and lapatinib ditosylate together may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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).
TERTIARY OBJECTIVES:
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.
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.
SECONDARY OBJECTIVES:
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).
TERTIARY OBJECTIVES:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01108 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |