Clinical trial · Interventional
ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer
A Phase II Study Of ZD1839 (NSC #715055) In Renal Cell Carcinoma Stage IV And Renal Cell Carcinoma Recurrent
NCT00014183CI-TRIAL-00041500completedPhase 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 kidney cancer. PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have recurrent or stage IV kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IV or recurrent renal cell carcinoma not amenable to potentially curative surgery * Evidence of disease progression * Measurable disease * At least 20 mm with conventional techniques OR * At least 10 mm with spiral CT scan * No brain metastases * Malignant tissue available PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * More than 2 months Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal (ULN) Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No prior allergy to compounds of similar chemical or biologic composition to ZD 1839 * No ongoing or active infection * No other uncontrolled illness or psychiatric condition that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 2 prior immunotherapy (interferon alfa or interleukin-2) regimens * At least 4 weeks since prior immunotherapy and recovered * No concurrent immunotherapy Chemotherapy: * No more than 1 prior chemotherapy regimen * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No prior therapy for metastatic disease * No other concurrent investigational agents * No concurrent oral retinoids
References
Publications (0)
Data not yet available
No reference posted for this study.