Clinical trial · Interventional
Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
NCT00028860CI-TRIAL-00011280completedPhase 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 more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.
Conditions
Conditions (2)
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 | Bladder Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of transitional cell carcinoma of the urothelium including bladder, ureter, and renal pelvis * T3b-4, N0, M0 OR * Any T, N1-3, M0 * Cystectomy within the past 8 weeks PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-1 Life expectancy: * At least 12 months Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than ULN * Albumin no greater than ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer * No active serious infection, other serious underlying medical condition, dementia, or significantly altered mental status that would preclude study participation * No known hypersensitivity to Cremophor EL * No pre-existing clinically significant grade 2 or greater neuropathy * No AIDS (HIV positivity alone allowed) * No known hypersensitivity to E. coli-derived products PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for malignancy * No neoadjuvant chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for malignancy Surgery: * See Disease Characteristics Other: * No other concurrent investigational therapy
References
Publications (0)
Data not yet available
No reference posted for this study.