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Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer

NCT00479089 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-11-02

Study results available
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Summary

Primary Objective:

1\. To compare the proportion of patients free from progression 9 months from the start of consolidation therapy with the combination of docetaxel and ZD1839 (Iressa) versus docetaxel alone. For the purposes of this protocol, "consolidation" therapy refers to treatment given at the time of maximal benefit from conventional front-line multi-agent chemotherapy.

Secondary Objective:

1\. To compare time to progression (TTP), overall survival (OS) and cause-specific survival (CSS) in the two arms. For completeness, these will be reported both from the initiation of consolidation chemotherapy, and from the completion of induction chemotherapy.

Conditions

Interventions

DRUG

Docetaxel

25 mg/m2 IV over 30 minutes for 4 weeks, followed by 2 weeks off therapy.

DRUG

ZD1839

250 mg by mouth daily, without break.

DRUG

Dexamethasone

Course #1: 3 doses of prophylactic Dexamethasone 4mg orally every 12 hours, starting the night before the Docetaxel infusion. Course #2: If no hypersensitivity reactions and no significant fluid retention during course 1, the Dexamethasone is reduced to 4mg orally twice daily on the day of therapy. Course #3 and subsequent courses: If no hypersensitivity reactions and no significant fluid retention during course 2, the Dexamethasone is reduced to 4mg orally one hour before treatment.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Arlene Siefker-Radtke, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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 NCT00479089 on ClinicalTrials.gov