Clinical trial · Interventional
Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
NCT00021099CI-TRIAL-00009090completedPhase 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)
Phase II trial to study the effectiveness of ixabepilone in treating patients who have progressive or metastatic urinary tract cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Distal Urethral Cancer | Distal Urethral Carcinoma | ALIAS | 0.90 |
| Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Proximal Urethral Cancer | Proximal Urethral Carcinoma | ALIAS | 0.90 |
| Recurrent Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Recurrent Urethral Cancer | Malignant Urethral Neoplasm | CURATED_BROADER | 0.80 |
| Regional Transitional Cell Cancer of the Renal Pelvis and Ureter | — | UNRESOLVED | — |
| Stage III Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Bladder Cancer |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ixabepilone)
- description
- Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: ixabepilone
Primary outcomes (1)
- measure
- The proportion of patients with clinical response measured using RECIST criteria
- timeFrame
- Up to 3 years
Secondary outcomes (1)
- measure
- Toxicity graded using the NCI CTC version 2.0
- timeFrame
- Up to 30 days after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed transitional cell carcinoma (TCC) of the urothelium(renal pelvis, ureter, bladder, or urethra) * Mixed histology carcinoma with a TCC component allowed * Progressive regional disease * Metastatic disease * Failed 1 and only 1 prior systemic chemotherapy regimen containing cisplatin or carboplatin in the adjuvant, neoadjuvant, or metastatic setting * May have included taxane-based therapy * Measurable disease outside prior irradiation field * Previously resected and irradiated CNS metastases with evidence of stable disease allowed * Performance status - ECOG 0-2 * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 mg/dL * AST no greater than 2.5 times upper limit of normal * Creatinine no greater than 1.5 mg/dL * No prior severe cardiovascular disease (American Heart Association class III or IV heart disease) * No uncontrolled congestive heart failure * No ventricular dysrhythmia * No active unresolved infection requiring parenteral antibiotics within the past week * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or clinically unsuspected organ-confined prostate cancer treated with prior prostatectomy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior systemic biologic response modifier therapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy * See Disease Characteristics * At least 4 weeks since prior major surgery and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.