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A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium


Phase 2
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

A Phase II Study Of Epothilone B Analogue BMS-247550 (NSC #710428) q21 Days In Advanced Carcinoma Of The Urothelium


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients with clinical response measured using RECIST criteria

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Robert Dreicer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02390

NCT ID:

NCT00021099

Start Date:

June 2001

Completion Date:

Related Keywords:

  • 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
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell
  • Urethral Neoplasms
  • Kidney Neoplasms
  • Ureteral Neoplasms
  • Urologic Neoplasms

Name

Location

Eastern Cooperative Oncology GroupBoston, Massachusetts  02215