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Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder

NCT01382706 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-09

Study results available
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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.

Conditions

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

Interventions

DRUG

docetaxel

Given IV

DRUG

lapatinib ditosylate

Given PO

OTHER

immunohistochemistry staining method

Correlative studies

GENETIC

fluorescence in situ hybridization

Correlative studies

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • David Quinn, M.D. · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-13
Primary Completion
2013-07-15
Completion
2017-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382706 on ClinicalTrials.gov