NCT00246974
Completed
Phase 2
An Open Randomised Phase II Study Of Gemcitabine Plus Cisplatin +/- Concomitant or Sequential ZD1839 in Patients With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
ConditionsBladder Cancer
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine
- Conditions
- Bladder Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Time to progression (TTP)
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Cisplatin + Gemcitabin
Intervention: Gemcitabine
1
Cisplatin + Gemcitabin
Intervention: Cisplatin
2
Cisplatin + Gemcitabin + Gefitinib
Intervention: Gemcitabine
2
Cisplatin + Gemcitabin + Gefitinib
Intervention: Cisplatin
2
Cisplatin + Gemcitabin + Gefitinib
Intervention: Gefitinib
Outcomes
Primary Outcomes
Time to progression (TTP)
Secondary Outcomes
- 6. Safety and tolerability
- 1. Response rate
- 2. Overall survival time
- 3. Time to treatment failure
- 4. Disease control rate
- 5. Duration of response
Study Sites (1)
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