Clinical trial · Interventional
Phase II Gemcitabine + Cisplatin +/- Iressa Bladder CCT
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
NCT00246974CI-TRIAL-00001723completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gefitinib | Drug | Gefitinib | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Cisplatin + Gemcitabin
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- Cisplatin + Gemcitabin + Gefitinib
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: Gefitinib
Primary outcomes (1)
- measure
- Time to progression (TTP)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.