Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
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ClinicalTrials.gov Identifier: NCT00021099 |
Recruitment Status :
Completed
First Posted : October 9, 2003
Last Update Posted : January 24, 2013
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Condition or disease | Intervention/treatment | Phase |
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Distal Urethral Cancer Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Regional Transitional Cell Cancer of the Renal Pelvis and Ureter Stage III Bladder Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Urethral Cancer Associated With Invasive Bladder Cancer | Drug: ixabepilone | Phase 2 |
OBJECTIVES:
I. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.
II. Assess the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no).
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium |
Study Start Date : | June 2001 |
Actual Primary Completion Date : | August 2007 |

Arm | Intervention/treatment |
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Experimental: Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: ixabepilone
Given IV
Other Names:
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- The proportion of patients with clinical response measured using RECIST criteria [ Time Frame: Up to 3 years ]
- Toxicity graded using the NCI CTC version 2.0 [ Time Frame: Up to 30 days after completion of study treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021099
United States, Massachusetts | |
Eastern Cooperative Oncology Group | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Robert Dreicer | Eastern Cooperative Oncology Group |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021099 |
Other Study ID Numbers: |
NCI-2012-02390 E3800 U10CA021115 ( U.S. NIH Grant/Contract ) CDR0000068747 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | October 9, 2003 Key Record Dates |
Last Update Posted: | January 24, 2013 |
Last Verified: | January 2013 |
Carcinoma Urinary Bladder Neoplasms Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Urethral Diseases Kidney Diseases Ureteral Diseases Epothilones Epothilone B Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |