drugset / Trial / NCT00479089

Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer

NCT00479089

Phase 2 Terminated 50 enrolled M.D. Anderson Cancer Center AstraZeneca · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-02
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gefitinib Small molecule 250 mg Oral
Comparator Dexamethasone Small molecule 4 mg Oral
Comparator Docetaxel Small molecule 25 mg/m2 Intravenous