Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy with gefitinib may kill more tumor cells. Phase II trial to study the effectiveness of combining chemotherapy with gefitinib in treating patients who have metastatic transitional cell cancer of the urothelium
PRIMARY OBJECTIVES: I. To describe the overall response proportion in patients with advanced carcinoma of the urothelial tract treated with cisplatin, gemcitabine (gemcitabine hydrochloride) and ZD1839 (gefitinib), given on a 21 day schedule, followed by maintenance ZD1839. SECONDARY OBJECTIVES: I. To describe the time to progression, progression-free survival, and overall survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin, gemcitabine and ZD1839, given on a 21 day schedule, followed by maintenance ZD1839. II. To evaluate the effect of epidermal growth factor receptor (EGFR) expression level on overall response rate and progression-free survival in patients with advanced carcinoma of the urothelial tract treated with cisplatin, gemcitabine and ZD1839, given on a 21 day schedule, followed by maintenance ZD1839. III. To assess the toxicity of the combination of cisplatin, gemcitabine and ZD1839 given on a 21 day schedule, followed by maintenance ZD1839 in patients with advanced carcinoma of the urothelial tract. OUTLINE: This is a multicenter study. Patients receive gemcitabine intravenously (IV) over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Patients also receive gefitinib orally (PO) once daily (QD) beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission, partial remission, or maintain stable disease continue gefitinib PO QD for 5 years or until disease progression or unacceptable toxicity occurs. Patients are followed at least every 3 months for 1 year and then at least every 6 months until disease progression or relapse.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cancer and Leukemia Group B
Chicago, Illinois, United States
Objective response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria and defined as either a complete or partial response
Exact 95% confidence intervals based on the binomial distribution will be computed.
Time frame: Up to 7 years
Toxicity rates assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Exact 95% confidence intervals based on the binomial distribution will be computed.
Time frame: Up to 7 years
Progression-free survival (PFS)
The Kaplan-Meier product limit method will be used to estimate the PFS.
Time frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years
Overall survival (OS)
The Kaplan-Meier product limit method will be used to estimate the OS.
Time frame: From the date of initiation of treatment to date of death due to any cause, assessed up to 7 years
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