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Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

NCT00859339 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-04-14

Study results available
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Summary

This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.

Conditions

  • Transitional Cell Carcinoma of the Bladder

Interventions

DRUG

Gemcitabine

Gemcitabine ( 1000 mg/m2) IV days 1 and 8

DRUG

Cisplatin

Cisplatin (70 mg/m2) IV day 1

DRUG

Sunitinib Malate

Sunitinib malate (37.5 mg) oral daily for days 1-14

PROCEDURE

Radical Cystectomy

Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Noah Hahn, M.D.

    lead OTHER

Principal Investigators

  • Noah Hahn, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States
  • United Kingdom

Study Locations

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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 NCT00859339 on ClinicalTrials.gov