drugset / Trial / NCT00479089
Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gefitinib | Small molecule | 250 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 4 mg | Oral |
| Comparator | Docetaxel | Small molecule | 25 mg/m2 | Intravenous |