Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
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ClinicalTrials.gov Identifier: NCT00002684 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 2013
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, 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: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Cancer Urethral Cancer | Drug: cisplatin Drug: ifosfamide Drug: paclitaxel | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors |
Study Start Date : | May 1995 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

- Efficacy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002684
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Dean F. Bajorin, MD | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00002684 |
Other Study ID Numbers: |
95-031 CDR0000064373 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-V95-0743 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | July 3, 2013 |
Last Verified: | July 2013 |
stage III bladder cancer recurrent bladder cancer stage IV bladder cancer squamous cell carcinoma of the bladder adenocarcinoma of the bladder |
recurrent urethral cancer distal urethral cancer proximal urethral cancer urethral cancer associated with invasive bladder cancer |
Urinary Bladder Neoplasms Urethral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Paclitaxel |
Ifosfamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |