Combination Chemotherapy Following Surgery in Treating Patients With Urinary Tract Cancer
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|ClinicalTrials.gov Identifier: NCT00028860|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients who have urinary tract cancer.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter||Biological: filgrastim Drug: carboplatin Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: paclitaxel Procedure: adjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial Of Adjuvant Chemotherapy For High Risk Transitional Cell Carcinoma Of The Urothelium|
|Study Start Date :||October 2001|
|Actual Study Completion Date :||October 2004|
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): NCT00028860
|United States, Louisiana|
|Tulane Cancer Center at Tulane University Hospital and Clinic|
|New Orleans, Louisiana, United States, 70112|
|Study Chair:||Raja Mudad, MD, FACP||Tulane University Health Sciences Center|