Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer - Full Text View

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

MedlinePlus related topics: Cancer

Drug Information available for: Ixabepilone

Genetic and Rare Diseases Information Center resources: Transitional Cell Carcinoma Urethral Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Kidney Cancer Renal Cancer

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: BMS-247550 epothilone B lactam Ixempra

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Robert Dreicer	Eastern Cooperative Oncology Group

More Information


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:


Carcinoma Urinary Bladder Neoplasms Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms 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

ClinicalTrials.gov processed this record on September 23, 2016