Clinical trial · Interventional
S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract
Evaluation of ZD1839 (NSC #715055) for Advanced Transitional Cell Carcinoma of the Urothelium, Phase II
NCT00014144CI-TRIAL-00008231completedPhase 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)
RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of cancer of the urinary tract. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have advanced cancer of the urinary tract.
Conditions
Conditions (3)
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 |
| Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZD 1839
- interventionNames
- Drug: gefitinib
Primary outcomes (1)
- measure
- Progression-free survival rate
- timeFrame
- From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- From date of registration until progression or death from any cause, whichever came first, assessed up to 3 years
- measure
- Confirmed complete and partial response to ZD 1839
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) not curable by surgery or radiotherapy * Any T, N0-3, M1 or unresectable M0 * Poorly differentiated TCC, predominant TCC with rare foci of squamous differentiation, or rare foci of adenocarcinoma allowed * Measurable disease * At least 1 lesion accessible for biopsy * Soft tissue disease that has been irradiated within the past 2 months not considered measurable disease * Progressive or recurrent disease after only 1 prior systemic chemotherapy regimen for advanced disease * No adenocarcinoma, small cell carcinoma, sarcoma, squamous cell carcinoma, or mixed histology PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm3 * Absolute granulocyte count at least 1,200/mm3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 2 times ULN Renal: * Creatinine no greater than 2 times ULN Other: * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) Chemotherapy: * See Disease Characteristics * No prior adjuvant chemotherapy * At least 28 days since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 28 days since prior radiotherapy and recovered Surgery: * See Disease Characteristics * At least 28 days since prior surgery and recovered Other: * No prior systemic therapy between biopsy and study entry * At least 28 days since prior intravesical therapy and recovered * No concurrent agents that induce CYP3A4 (e.g., nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, or St. John's Wort)
References
Publications (0)
Data not yet available
No reference posted for this study.