Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium
Sponsor: Tulane University Health Sciences Center
This PHASE2 trial investigates Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter and is currently completed. Tulane University Health Sciences Center leads this study, which shows 6 recorded versions since 2001 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)OBJECTIVES: * Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel, ifosfamide, carboplatin, and gemcitabine. * Determine the tolerability and feasibility of this regimen in these patients. OUTLINE: Patients are stratified according to disease stage. Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses. Beginning 3 weeks after the completion of the second course of chemotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of...
OBJECTIVES:
* Determine the time to treatment failure and disease-free survival in patients with high-risk transitional cell carcinoma of the urothelium treated with adjuvant paclitaxel, ifosfamide, carboplatin, and gemcitabine. * Determine the tolerability and feasibility of this regimen in these patients.
OUTLINE: Patients are stratified according to disease stage.
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour on day 1, ifosfamide IV over 1 hour on days 1-3, and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses.
Beginning 3 weeks after the completion of the second course of chemotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Patients also receive G-CSF SC once daily on days 2-6 and again beginning on day 9 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 months, every 6 months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Oct 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Tulane University Health Sciences Center
For direct contact, visit the study record on ClinicalTrials.gov .