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Trial record 5 of 5 for:    "Transitional Cell Carcinoma" | "Gefitinib"

Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00479089
Recruitment Status : Terminated (Study halted due to drug sponsor decision to not continue.)
First Posted : May 25, 2007
Results First Posted : October 6, 2015
Last Update Posted : November 2, 2015
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder Cancer
Interventions Drug: Docetaxel
Drug: ZD1839
Drug: Dexamethasone
Enrollment 50
Recruitment Details Recruitment Period: From April of 2004 to November of 2007, fifty patients with metastatic or surgically unresectable urothelial cancer were enrolled at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Weekly Docetaxel Weekly Docetaxel + ZD1839
Hide Arm/Group Description Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Weekly Docetaxel Weekly Docetaxel + ZD1839 Total
Hide Arm/Group Description Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break. Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
64
(51 to 76)
62
(40 to 80)
64
(40 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
4
  16.0%
18
  72.0%
22
  44.0%
Male
21
  84.0%
7
  28.0%
28
  56.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Number of Participants Free From Progression 9 Months From Start of Consolidation Therapy
Hide Description The proportion of participants’ progression free at 9 months compared between treatments using chi-square. Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.
Time Frame Assessment at 9 Months of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
In order to test the trial hypotheses for the two cohorts progression at nine months, a sample size of 45 participants for each arm was required. Accrual was not met to assess the outcome hypotheses thus no participant analysis available.
Arm/Group Title Weekly Docetaxel Weekly Docetaxel + ZD1839
Hide Arm/Group Description:
Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Median Overall Survival
Hide Description Overall survival was summarized using the Kaplan-Meier estimation.
Time Frame Baseline till participant death or end of follow-up period, assessed every 4 weeks, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis by intent to treat population with all participants treated included.
Arm/Group Title Weekly Docetaxel Weekly Docetaxel + ZD1839
Hide Arm/Group Description:
Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
Overall Number of Participants Analyzed 25 25
Median (Full Range)
Unit of Measure: Months
18.0
(3.4 to 92)
16.6
(3.9 to 95.9)
3.Secondary Outcome
Title Median Progression Free Survival From Trial Enrollment for Overall Study
Hide Description Progressive disease was defined as at least a 25% increase from baseline, of the sum of the products of the two greatest dimensions of representative measurable lesions. Increasing severity in symptoms due to progressive tumor was also counted as progression even if they were not accompanied by an objective indicator on radiographic imaging. The development of any new measurable lesions was considered evidence of progressive cancer as well.
Time Frame From trial enrollment to disease progression or death, up to five years
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis by intent to treat population with all participants treated included.
Arm/Group Title Weekly Docetaxel Weekly Docetaxel + ZD1839
Hide Arm/Group Description:
Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
Overall Number of Participants Analyzed 25 25
Median (Full Range)
Unit of Measure: Months
3.7
(0.7 to 10.4)
4.4
(1.1 to 13.9)
Time Frame Clinical assessment at the end of each 6-week treatment where data on symptom status, pain medication use, and acute and cumulative toxicity recorded. Overall collection period: May 2004 to October 2013.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Weekly Docetaxel Weekly Docetaxel + ZD1839
Hide Arm/Group Description Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
All-Cause Mortality
Weekly Docetaxel Weekly Docetaxel + ZD1839
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Weekly Docetaxel Weekly Docetaxel + ZD1839
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Weekly Docetaxel Weekly Docetaxel + ZD1839
Affected / at Risk (%) Affected / at Risk (%)
Total   6/25 (24.00%)   6/25 (24.00%) 
Blood and lymphatic system disorders     
Anemia  1  4/25 (16.00%)  3/25 (12.00%) 
Neutropenia  1  0/25 (0.00%)  1/25 (4.00%) 
Thrombocytopenia  1  1/25 (4.00%)  1/25 (4.00%) 
Eye disorders     
Watery eyes  1  0/25 (0.00%)  2/25 (8.00%) 
Gastrointestinal disorders     
Constipation  1  0/25 (0.00%)  2/25 (8.00%) 
Dehydration  1  0/25 (0.00%)  1/25 (4.00%) 
Diarrhea  1  0/25 (0.00%)  4/25 (16.00%) 
Dysgeusia  1  1/25 (4.00%)  0/25 (0.00%) 
Gastritis  1  0/25 (0.00%)  1/25 (4.00%) 
Nausea/Vomiting  1  1/25 (4.00%)  2/25 (8.00%) 
General disorders     
Fatigue  1  6/25 (24.00%)  3/25 (12.00%) 
Weakness  1  1/25 (4.00%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Hypomagnesemia  1  0/25 (0.00%)  2/25 (8.00%) 
Nervous system disorders     
Neuropathy  1  5/25 (20.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Renal Insufficiency  1  1/25 (4.00%)  0/25 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/25 (0.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/25 (0.00%)  6/25 (24.00%) 
Dry skin  1  0/25 (0.00%)  1/25 (4.00%) 
Edema  1  1/25 (4.00%)  1/25 (4.00%) 
Nail changes  1  0/25 (0.00%)  1/25 (4.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Early termination leading to small numbers of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arlene Siefker-Radtke, MD/Associate Professor, Genitourinary Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2830
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00479089     History of Changes
Other Study ID Numbers: 2003-0767
NCI-2010-00595 ( Registry Identifier: NCI CTRP )
First Submitted: May 24, 2007
First Posted: May 25, 2007
Results First Submitted: July 27, 2015
Results First Posted: October 6, 2015
Last Update Posted: November 2, 2015