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Sponsors and Collaborators: |
M.D. Anderson Cancer Center AstraZeneca |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00479089 |
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 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.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: Docetaxel Drug: ZD1839 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Weekly Docetaxel (Taxotere) Vs. Weekly Docetaxel in Combination With ZD1839 (Iressa®) As Consolidation Therapy For Metastatic Urothelial Cancer Following Maximal Response To Multi-Agent Chemotherapy |
Estimated Enrollment: | 90 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Weekly Docetaxel
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Drug: Docetaxel
25 mg/m2 for 4 weeks, followed by 2 weeks off therapy.
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2: Active Comparator
Weekly Docetaxel + ZD1839
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Drug: Docetaxel
25 mg/m2 for 4 weeks, followed by 2 weeks off therapy.
Drug: ZD1839
250 mg PO daily, without break.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Serum creatinine greater than 2.5 mg/dL , or a creatinine clearance (either measured or estimated by Cockcroft formula) of less than 25 mL/min: CLcr
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Arlene Siefker-Radtke, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Arlene Siefker-Radtke, MD/Assistant Professor ) |
Study ID Numbers: | 2003-0767 |
Study First Received: | May 24, 2007 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00479089 History of Changes |
Health Authority: | United States: Institutional Review Board |
Transitional Cell Carcinoma Urothelium Urothelial Cancer Bladder Cancer Docetaxel |
Taxotere ZD1839 Gefitinib Iressa Consolidation Therapy |
Urinary Tract Neoplasm Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms |
Protein Kinase Inhibitors Carcinoma Docetaxel Urologic Diseases Bladder Neoplasm Gefitinib Transitional Cell Carcinoma |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Gefitinib |