Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00021099
First received: July 11, 2001
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
Ixabepilone
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- The proportion of patients with clinical response measured using RECIST criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity graded using the NCI CTC version 2.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
| Enrollment: | 45 |
| Study Start Date: | June 2001 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: ixabepilone
Given IV
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021099
Locations
| United States, Massachusetts | |
| Eastern Cooperative Oncology Group | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Robert Dreicer | Eastern Cooperative Oncology Group |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00021099 History of Changes |
| Other Study ID Numbers: | NCI-2012-02390, E3800, U10CA021115, CDR0000068747 |
| Study First Received: | July 11, 2001 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Urethral Diseases Kidney Diseases Ureteral Diseases Epothilone B Epothilones Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013