Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT

AstraZeneca125 enrolled

Overview

The primary objective of the study is to assess the activity of ZD1839 250 mg once daily in addition to the standard chemotherapy in patients with advanced or metastatic transitional cell carcinoma of the urothelium by estimating the time to progression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

125

Conditions

Bladder Cancer

Interventions

GemcitabineDRUG

intravenous

CisplatinDRUG

intravenous

GefitinibDRUG

oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically-confirmed transitional cell carcinoma of the urothelium * Locally advanced or metastatic disease * At least one measurable lesion as defined by RECIST * Chemotherapy-naiv Exclusion Criteria: * Previous chemotherapy or other systemic antitumour therapy * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ or locally limited prostate cancer

Locations (14)

Research Site

Aachen, Germany

Research Site

Augsburg, Germany

Research Site

Berlin, Germany

Research Site

Outcomes

Primary Outcomes

Time to progression (TTP)

Secondary Outcomes

1. Response rate

2. Overall survival time

3. Time to treatment failure

4. Disease control rate

5. Duration of response

6. Safety and tolerability

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.