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Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer



Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

For Condition: Bladder Cancer,Urethral Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effects of combination chemotherapy with cisplatin, ifosfamide, and paclitaxel in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.
Details: OBJECTIVES: - Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies). OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven unresectable or metastatic urothelial cancer - No transitional cell histologies - Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count greater than 150,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 55 mL/min Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - No other concurrent malignancy except basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior systemic chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 3 weeks since prior radiotherapy Surgery - Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DeanBajorin,  Study Chair,  Memorial Sloan-Kettering Cancer Center

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Dean  Bajorin 646-422-4333


Additional Information:
Study ID Numbers:  CDR0000064373;  MSKCC-95031,NCI-V95-0743
Study Start Date: 
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002684

Other Urethral Cancer Studies:
1. Bortezomib in Treating Patients With Advanced Transitional Cell Carcinoma of the Urothelium

2. Short-Term Low-Dose Interferon alfa in Treating Patients With Cancer of the Urothelium

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

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

5. Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy

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Other Urethral Cancer Clinical Trials
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Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
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