Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Ixabepilone in Treating Patients With Advanced Urinary Tract Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	ECOG-E3800 E3800, NCT00021099

Objectives

1. Determine the response rate of patients with advanced carcinoma of the urothelium treated with ixabepilone.
2. Assess the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• 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

  OR




• 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

Prior/Concurrent Therapy:

Biologic therapy:

• No prior systemic biologic response modifier therapy

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 4 weeks since prior major surgery and recovered

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No prior severe cardiovascular disease (American Heart Association class III or IV heart disease)
• No uncontrolled congestive heart failure
• No ventricular dysrhythmia

Other:

• 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

Expected Enrollment

A total of 20-45 patients will be accrued for this study within 12-19 months.

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.

Dreicer R, Li S, Manola J, et al.: Phase 2 trial of epothilone B analog BMS-247550 (ixabepilone) in advanced carcinoma of the urothelium (E3800): a trial of the Eastern Cooperative Oncology Group. Cancer 110 (4): 759-63, 2007.[PUBMED Abstract]

Dreicer R, Li S, Manola J, et al.: Phase II trial of epothilone B analogue BMS-247550 in advanced carcinoma of the urothelium (E3800): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 24 (Suppl 18): A-4543, 2006.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Robert Dreicer, MD, FACP, Protocol chair		Ph: 216-445-4623; 800-862-7798 Email: dreicer@ccf.org

Registry Information
Official Title		A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium
Trial Start Date		2001-05-18
Registered in ClinicalTrials.gov		NCT00021099
Date Submitted to PDQ		2001-05-15
Information Last Verified		2004-11-08
NCI Grant/Contract Number		CA21115

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