Clinical trial · Interventional
SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
Phase II Study on SCH 66336 (Farnesyl Protein Transferase Inhibitor) and Gemcitabine as Second Line Treatment in Advanced Metastatic Urothelial Cancer - EORTC Study 16997
NCT00006351CI-TRIAL-00008082completedPhase 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SCH 66336 and gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of SCH 66336 plus gemcitabine 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| lonafarnib | Drug | Lonafarnib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or unresectable primary transitional cell carcinoma of the urinary tract, including bladder, ureter, and renal pelvis * At least one measurable lesion * 20 mm or greater by conventional techniques OR * 10 mm or greater by spiral CT scan * Must have received one (and only one) prior chemotherapy regimen for advanced or metastatic disease * No clinical signs of brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5 times ULN with liver metastases) Renal: * Creatinine no greater than 1.7 mg/dL Cardiovascular: * Normal cardiac function * No ischemic heart disease within the past 6 months * Normal 12 lead ECG Other: * No prior gastrectomy or any gastrointestinal disease that may impair absorption of SCH 66336 * No unstable systemic disease * No active uncontrolled infection * No psychological, familial, sociological, or geographical condition that would preclude study * No prior or concurrent other malignancy except cone biopsied carcinoma in situ of the cervix or adequately treated basal or squamous cell skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No prior farnesyl protein transferase inhibitors or gemcitabine Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * At least 2 weeks since prior major surgery Other: * No other concurrent anticancer agents * No other concurrent investigational therapy
References
Publications (1)
- RESULTTheodore C, Geoffrois L, Vermorken JB, Caponigro F, Fiedler W, Chollet P, Ravaud A, Peters GJ, de Balincourt C, Lacombe D, Fumoleau P. Multicentre EORTC study 16997: feasibility and phase II trial of farnesyl transferase inhibitor & gemcitabine combination in salvage treatment of advanced urothelial tract cancers. Eur J Cancer. 2005 May;41(8):1150-7. doi: 10.1016/j.ejca.2005.02.015. PMID 15911238