Trial Outcomes & Findings for Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer (NCT NCT00479089)

Last Updated: 2015-11-02

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Assessment at 9 Months of therapy

Results posted on

2015-11-02

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Weekly Docetaxel Docetaxel 25 mg/m\^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.	Weekly Docetaxel + ZD1839 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 Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weekly Docetaxel n=25 Participants Docetaxel 25 mg/m\^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.	Weekly Docetaxel + ZD1839 n=25 Participants 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 n=50 Participants Total of all reporting groups
Age, Continuous	64 years n=99 Participants	62 years n=107 Participants	64 years n=206 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	18 Participants n=107 Participants	22 Participants n=206 Participants
Sex: Female, Male Male	21 Participants n=99 Participants	7 Participants n=107 Participants	28 Participants n=206 Participants
Region of Enrollment United States	25 participants n=99 Participants	25 participants n=107 Participants	50 participants n=206 Participants

PRIMARY outcome

Timeframe: Assessment at 9 Months of therapy

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline till participant death or end of follow-up period, assessed every 4 weeks, up to 5 years.

Population: Analysis by intent to treat population with all participants treated included.

Overall survival was summarized using the Kaplan-Meier estimation.

Outcome measures

Outcome measures
Measure	Weekly Docetaxel n=25 Participants Docetaxel 25 mg/m\^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.	Weekly Docetaxel + ZD1839 n=25 Participants 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.
Median Overall Survival	18.0 Months Interval 3.4 to 92.0	16.6 Months Interval 3.9 to 95.9

SECONDARY outcome

Timeframe: From trial enrollment to disease progression or death, up to five years

Population: Analysis by intent to treat population with all participants treated included.

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.

Outcome measures

Outcome measures
Measure	Weekly Docetaxel n=25 Participants Docetaxel 25 mg/m\^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.	Weekly Docetaxel + ZD1839 n=25 Participants 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.
Median Progression Free Survival From Trial Enrollment for Overall Study	3.7 Months Interval 0.7 to 10.4	4.4 Months Interval 1.1 to 13.9

Adverse Events

Weekly Docetaxel

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Weekly Docetaxel + ZD1839

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Arlene Siefker-Radtke, MD/Associate Professor, Genitourinary Medical Oncology

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-2830

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Weekly Docetaxel n=25 participants at risk Docetaxel 25 mg/m\^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.	Weekly Docetaxel + ZD1839 n=25 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	0.00% 0/25 • 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.	24.0% 6/25 • 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.
Blood and lymphatic system disorders Anemia	16.0% 4/25 • 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.	12.0% 3/25 • 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.
Gastrointestinal disorders Constipation	0.00% 0/25 • 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.	8.0% 2/25 • 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.
Gastrointestinal disorders Dehydration	0.00% 0/25 • 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.	4.0% 1/25 • 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.
Gastrointestinal disorders Diarrhea	0.00% 0/25 • 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.	16.0% 4/25 • 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.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/25 • 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.	4.0% 1/25 • 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.
Gastrointestinal disorders Dysgeusia	4.0% 1/25 • 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.	0.00% 0/25 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/25 • 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.	4.0% 1/25 • 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.
Skin and subcutaneous tissue disorders Edema	4.0% 1/25 • 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.	4.0% 1/25 • 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.
General disorders Fatigue	24.0% 6/25 • 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.	12.0% 3/25 • 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.
Gastrointestinal disorders Gastritis	0.00% 0/25 • 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.	4.0% 1/25 • 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.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/25 • 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.	8.0% 2/25 • 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.
Skin and subcutaneous tissue disorders Nail changes	0.00% 0/25 • 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.	4.0% 1/25 • 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.
Gastrointestinal disorders Nausea/Vomiting	4.0% 1/25 • 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.	8.0% 2/25 • 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.
Nervous system disorders Neuropathy	20.0% 5/25 • 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.	4.0% 1/25 • 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.
Blood and lymphatic system disorders Neutropenia	0.00% 0/25 • 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.	4.0% 1/25 • 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.
Renal and urinary disorders Renal Insufficiency	4.0% 1/25 • 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.	0.00% 0/25 • 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.
Blood and lymphatic system disorders Thrombocytopenia	4.0% 1/25 • 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.	4.0% 1/25 • 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.
Eye disorders Watery eyes	0.00% 0/25 • 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.	8.0% 2/25 • 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.
General disorders Weakness	4.0% 1/25 • 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.	0.00% 0/25 • 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.