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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00021099
Other study ID # NCI-2012-02390
Secondary ID E3800U10CA021115
Status Completed
Phase Phase 2
First received July 11, 2001
Last updated January 23, 2013
Start date June 2001

Study information

Verified date January 2013
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
ixabepilone
Given IV

Locations

Country Name City State
United States Eastern Cooperative Oncology Group Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients with clinical response measured using RECIST criteria Up to 3 years No
Secondary Toxicity graded using the NCI CTC version 2.0 Up to 30 days after completion of study treatment Yes
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