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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer

BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer



BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer

For Condition: Bladder Cancer,Urethral Cancer,transitional cell cancer of the renal pelvis and ureter
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have progressive or metastaticurinary tract cancer.
Details: OBJECTIVES: - Determine the response rate of patients with advanced carcinoma of the urothelium treated with BMS-247550. - Assess the toxicity of this drug in these patients. OUTLINE: Patients are stratified according to prior treatment with taxanes (yes vs no). Patients receive BMS-247550 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. PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 12-19 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RobertDreicer,  Study Chair,  Cleveland Clinic Cancer Center

CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay,  Wisconsin,  54307-3453
United States
Recruiting Gerald  Bayer 920-433-8889

CCOP - Toledo Community Hospital *Recruiting*
Toledo,  Ohio,  43623-3456
United States
Recruiting Paul  Schaefer 419-843-6147

Sky Ridge Medical Center *Recruiting*
Lone Tree,  Colorado,  80124
United States
Recruiting Dennis  Carter 720-225-4211

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111-2497
United States
Recruiting Lori  Goldstein 215-728-2689

Pretoria Academic Hospital *Recruiting*
Pretoria,  ,  0001
South Africa
Recruiting Coenraad  Slabber 27-12-354-1054

CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver,  Colorado,  80224
United States
Recruiting Eduardo  Pajon 303-777-2663

CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale,  Arizona,  85259-5404
United States
Recruiting Tom  Fitch 480-301-9875

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

CCOP - Illinois Oncology Research Association *Recruiting*
Peoria,  Illinois,  61602
United States
Recruiting John  Kugler 309-636-3605

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Al  Benson 312-695-1382

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Thomas  Habermann 507-284-2511

Medical Center of Aurora - South Campus *Recruiting*
Aurora,  Colorado,  80012-0000
United States
Recruiting Sami  Diab 303-418-7600

CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids,  Iowa,  52403-1206
United States
Recruiting Martin  Wiesenfeld 319-363-8303

Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago,  Illinois,  60611-4494
United States
Recruiting Timothy  Kuzel 312-469-3748

Boulder Community Hospital *Recruiting*
Boulder,  Colorado,  80301-9019
United States
Recruiting John  Fleagle 303-440-2399

Rocky Mountain Cancer Centers *Recruiting*
Thornton,  Colorado,  80260
United States
Recruiting Alvin  Otsuka 303-386-7622

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

St. Mary-Corwin Regional Medical Center *Recruiting*
Pueblo,  Colorado,  81004
United States
Recruiting Marlow  Sloan 719-560-6000

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Suresh  Nair 570-271-6413

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792-0001
United States
Recruiting James  Stewart 608-265-8131

Longmont United Hospital *Recruiting*
Longmont,  Colorado,  80501
United States
Recruiting Robert  Fisher 303-485-4132

Rocky Mountain Cancer Centers - Rose *Recruiting*
Denver,  Colorado,  80220
United States
Recruiting Scot  Sedlacek 303-321-0302

Swedish Medical Center *Recruiting*
Englewood,  Colorado,  80110
United States
Recruiting Marshall  Davis 303-788-5860

Penrose Cancer Center *Recruiting*
Colorado Springs,  Colorado,  80933
United States
Recruiting Robert  Sayre 719-577-2555

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Carla  Falkson 205-975-2691

Presbyterian-St Luke's Medical Center *Recruiting*
Denver,  Colorado,  80218
United States
Recruiting Robert  Jotte 303-388-4876

CCOP - Northern New Jersey *Recruiting*
Hackensack,  New Jersey,  07601
United States
Recruiting Richard  Rosenbluth 201-996-5917

CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls,  South Dakota,  57104
United States
Recruiting Loren  Tschetter 605-328-8044

St. Joseph Hospital *Recruiting*
Denver,  Colorado,  80218-1191
United States
Recruiting Michael  McLaughlin 303-861-3302

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-6307
United States
Recruiting Bruce  Roth 615-343-4070

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

Porter Adventist Hospital *Recruiting*
Denver,  Colorado,  80210
United States
Recruiting David  Trevarthen 303-788-8675

CCOP - Merit Care Hospital *Recruiting*
Fargo,  North Dakota,  58122
United States
Recruiting Preston  Steen 701-234-6161

MetroHealth Medical Center *Recruiting*
Cleveland,  Ohio,  44109
United States
Recruiting Edward  Mansour 216-778-4394


Additional Information:
Study ID Numbers:
  CDR0000068747;  ECOG-E3800
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021099

Other Bladder Cancer Studies:
1. Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

2. Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

3. BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer

4. Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Bladder Cancer

5. Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer

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BMS-247550 in Treating Patients With Advanced Urinary Tract Cancer

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