Phase II Study Of Cisplatin, Gemcitabine, And ZD 1839 (IRESSA) (IND #61187; NSC 715055) For The Treatment Of Advanced Urothelial Tract Carcinoma
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Up to 7 years
No
George Philips
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-02818
NCT00041106
May 2002
Name | Location |
---|---|
Cancer and Leukemia Group B | Chicago, Illinois 60606 |