Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency
NCT00005644CI-TRIAL-00067386completedPhase 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 cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
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 |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium * Mixed histologies containing a component of transitional cell carcinoma allowed * Bidimensionally measurable disease * No clinical evidence of CNS metastases * Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR * Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR * SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 3.0 mg/dL * Glomerular filtration rate no greater than 50 mL/min Cardiovascular: * No history of American Heart Association class III or IV heart disease * No uncontrolled congestive heart failure * No severe cardiac arrhythmias Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No preexisting peripheral neuropathy grade 2 or greater * No active unresolved infection requiring parenteral antibiotics within the past 7 days * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior systemic biologic response modifier therapy for advanced disease * Prior intravesical BCG for superficial disease allowed Chemotherapy: * Prior intravesical chemotherapy for superficial disease allowed * No prior chemotherapy for advanced disease * At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery and recovered Other: * No concurrent hemodialysis
References
Publications (0)
Data not yet available
No reference posted for this study.