Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder

Conditions

• Recurrent Bladder Cancer
• Stage III Bladder Cancer
• Stage IV Bladder Cancer
• Transitional Cell Carcinoma of the Bladder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• docetaxel — DRUG
  Given IV
• lapatinib ditosylate — DRUG
  Given PO
• immunohistochemistry staining method — OTHER
  Correlative studies
• fluorescence in situ hybridization — GENETIC
  Correlative studies
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

Start date

Jun 13, 2011

Status verified

Sep 2025

Primary completion

Jul 15, 2013

Completion

Dec 15, 2017

Study Design

Enrollment

15 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  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.

Primary Outcome Measure

Progression-free Survival Rate [ Time Frame: At 12 weeks ]

Locations (1)

Find similar trials in Los Angeles, CA

Related Studies

• Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
  Recruiting · University of Washington · Tampa, Florida